Spondylitis, Ankylosing Clinical Trial
— RE-EMBARKOfficial title:
A MULTICENTER OPEN-LABEL STUDY OF ETANERCEPT WITHDRAWAL AND RETREATMENT IN SUBJECTS WITH NON-RADIOGRAPHIC AXIAL SPONDYLOARTHRITIS WHO ACHIEVED ADEQUATE 24 WEEK RESPONSE
| Verified date | June 2020 |
| Source | Pfizer |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
The purpose of this study is to study the benefits and risks of etanercept withdrawal in patients who have achieved a significant clinical response.
| Status | Completed |
| Enrollment | 210 |
| Est. completion date | September 6, 2019 |
| Est. primary completion date | May 28, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 49 Years |
| Eligibility |
Inclusion Criteria: - diagnosis of axial SpA duration of symptoms >3 months and <5 years back pain with a less than favorable response to NSAIDs Exclusion Criteria: - radiological sacroiliitis previous treatment with TNF inhibitor, biologic, immunosuppressive |
| Country | Name | City | State |
|---|---|---|---|
| Australia | Genesis Research Services Pty Ltd | Broadmeadow | New South Wales |
| Australia | Hunter Imaging Group | Cardiff | New South Wales |
| Australia | Pacific Radiology | Maroochydore | Queensland |
| Australia | Rheumatology Research Centre | Maroochydore | Queensland |
| Australia | SKG Radiology Hollywood Hospital | Nedlands | Western Australia |
| Australia | Benson Radiology | North Adelaide | South Australia |
| Australia | SKG Radiology Subiaco | Subiaco | Western Australia |
| Australia | R.K. Will Pty Ltd | Victoria Park | Western Australia |
| Australia | The Queen Elizabeth Hospital | Woodville South | South Australia |
| Belgium | Reumaclinic | Genk | |
| Belgium | Private Practice Rheumatology | Sint-Niklaas | OVL |
| Colombia | Preventive Care SAS | Chía | Cundinamarca |
| Colombia | Centro Integral de Reumatologia Reumalab S.A.S. | Medellin | Antioquia |
| Colombia | Hospital Pablo Tobon Uribe | Medellin | Antioquia |
| Czechia | Affidea Praha s.r.o. | Praha 11 | |
| Czechia | Revmatologicky ustav | Praha 2 | |
| Czechia | Lekarna Hradebni s.r.o. | Uherske Hradiste | |
| Czechia | MEDICAL PLUS, s.r.o. | Uherske Hradiste | |
| Czechia | Uherskohradist' ska nemocnice a.s. | Uherske Hradiste | |
| Finland | Helsinki University Hospital | Helsinki | |
| Finland | HYKS, Meilahden kolmiosairaala | Helsinki | |
| Finland | Kiljavan Laaketutkimus Oy | Hyvinkaa | |
| France | Service d'Imagerie Guilloz | Nancy | |
| France | Hopital Cochin Pavillon Hardy B4 | Paris | |
| France | Pharmacie-Secteur Essais cliniques | Paris | |
| France | CHU de Rennes, Hopital Sud | Rennes | |
| France | CHU PURPAN, Hopital Pierre-Paul Riquet | Toulouse cedex 9 | |
| France | Pharmacie | Toulouse cedex 9 | |
| France | Pharmacie Essais cliniques | Vandoeuvre les Nancy | |
| France | CHU de Nancy - Hopital de Brabois | Vandoeuvre-les-Nancy cedex | |
| Germany | Apotheke am Tierpark | Berlin | |
| Germany | Charité Universitaetsmedizin Berlin | Berlin | |
| Germany | Charité Universitaetsmedizin Berlin | Berlin | |
| Germany | Praxis für radiologische Diagnostik | Berlin | |
| Germany | Rheumatologische Schwerpunktpraxis | Berlin | |
| Germany | Schlosspark-Klinik GmbH | Berlin | |
| Germany | Mvz Agilomed | Chemnitz | |
| Germany | Rheumazentrum Ruhrgebiet | Herne | NRW |
| Germany | Universitaetskliniken Koeln | Koeln | |
| Germany | Medizinische Klinik und Poliklinik IV | Muenchen | Bavaria |
| Hungary | Qualiclinic Kft. | Budapest | |
| Hungary | VITAL MEDICAL CENTER Orvosi es Fogorvosi Kozpont | Veszprem | |
| Netherlands | READE | Amsterdam | |
| Netherlands | LUMC | Leiden | |
| Poland | Nzoz McD Voxel | Bydgoszcz | |
| Poland | Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob | Bydgoszcz | |
| Poland | Zaklad Radiologii i Diagnostyki Obrazowej | Bydgoszcz | |
| Poland | Centrum Kliniczno-Badawcze J. Brzezicki, B. Gornikiewicz-Brzezicka Lekarze Spolka Partnerska | Elblag | |
| Poland | Samodzielny Publiczny Zespol Opieki Zdrowotnej | Koscian | |
| Poland | Reumed Sp z.o.o. Zespool Poradni Specjalistycznych Filia nr 1 | Lublin | |
| Poland | RCMed | Nowy Duninow | |
| Poland | Diagnostic-Med Centrum Diagnostyki Radiologicznej | Poznan | |
| Poland | RCMed | Sochaczew | |
| Poland | SANUS Szpital Specjalistyczny Sp. z o.o. | Stalowa Wola | |
| Poland | Nasz Lekarz Przychodnie Medyczne | Torun | |
| Poland | Medycyna Kliniczna | Warszawa | |
| Poland | Reumatika-Centrum Reumatologii NZOZ | Warszawa | |
| Poland | Centrum Medyczne OPOROW | Wroclaw | |
| Spain | Complexo Hospitalario Universitario A Coruna | La Coruna | |
| Spain | Hospital San Rafael | La Coruna | |
| Spain | Hospital Universitario de Canarias | San Cristobal de la Laguna | Santa CRUZ DE Tenerife |
| Spain | Complejo Hospitalario Universitario Santiago | Santiago de Compostela | A Coruna |
| Spain | Complejo Hospitalario Regional Virgen Macarena | Sevilla | |
| Sweden | Sahlgrenska University Hospital | Gothenburg | |
| Sweden | Skanes University Hospital Malmo | Malmo | |
| Sweden | Akademiska sjukhuset | Uppsala | |
| Taiwan | Kaohsiung Medical University Hospital | Kaohsiung | |
| Taiwan | China Medical University Hospital | Taichung | |
| Taiwan | Chung Shan Medical University | Taichung | |
| Taiwan | Chung Shan Medical University Hospital | Taichung | |
| United States | Northwestern Medical Group; Division of Rheumatology | Chicago | Illinois |
| United States | Northwestern Memorial Hospital | Chicago | Illinois |
| United States | Northwestern University Clinical and Translational Sciences Institute (NUCATS) | Chicago | Illinois |
| United States | Altoona Center for Clinical Research | Duncansville | Pennsylvania |
| United States | Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania |
| United States | Winthrop University Hospital, Clinical Trials Center | Mineola | New York |
| United States | Gulf Region Clinical Research Institute | Pensacola | Florida |
| United States | Oregon Health and Science University | Portland | Oregon |
| United States | Oregon Health and Science University Research Pharmacy | Portland | Oregon |
| United States | Seattle Rheumatology Associates | Seattle | Washington |
| United States | Swedish Medical Center | Seattle | Washington |
| United States | Swedish Medical Center Investigational Drug Services Pharmacy | Seattle | Washington |
| Lead Sponsor | Collaborator |
|---|---|
| Pfizer |
United States, Australia, Belgium, Colombia, Czechia, Finland, France, Germany, Hungary, Netherlands, Poland, Spain, Sweden, Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants Who Experienced Flare Within 40 Weeks Following Withdrawal of 24 Weeks of Etanercept Treatment | Participants who experienced ASDAS-Erythrocyte Sedimentation Rate (ESR) level of >=2.1 were defined as being flared. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in milligram per liter (mg/L) and ESR measured in millimeter per hour (mm/hr). Percentage of participants who flared within 40 weeks after the withdrawal of Etanercept treatment of 24 weeks in Induction period are reported in this outcome measure. | Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64) | |
| Secondary | Time to Flare Following Withdrawal of Etanercept Treatment | Participants who experienced ASDAS-ESR level of >=2.1 were defined as being flared. Time to experience flare in participants was defined as time to achieve ASDAS-ESR level of >=2.1 after the withdrawal of Etanercept treatment of 24 weeks in induction period. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. | Within 40 weeks after Etanercept withdrawal (from Week 24 to Week 64) | |
| Secondary | Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 1 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 2 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<)1.3: Observed Cases (OC): Period 3 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP. | Week 68, 72, 76 | |
| Secondary | Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 1 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 2 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants With Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Less Than (<) 1.3: Last Observation Carried Forward (LOCF): Period 3 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0 <= ASDAS-CRP <1.3; moderate disease activity: 1.3 <= ASDAS-CRP <2.1; high disease activity: 2.1 <= ASDAS-CRP <=3.5; very high disease activity: 3.5 < ASDAS-CRP. | Week 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 1 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from [Bath Ankylosing Spondylitis Functional Index] BASFI) and inflammation (from [Bath Ankylosing Spondylitis Disease Activity Index] BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 2 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Observed Cases (OC): Period 3 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 1 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 2 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders were defined as participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on a 0 to 10 cm scale (0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity) in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains were measured on a 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS 20) Response: Last Observation Carried Forward (LOCF): Period 3 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 20 responders: participants with at least 20% improvement from baseline in disease activity and an absolute change of at least 1 unit on 0 to 10 cm scale(0=no disease activity; 10=high disease activity, where higher scores indicated higher disease activity)in 3 or more domains, and no worsening of >=20% and absolute change 1 unit in the remaining domain. All 4 domains measured on 0-100 millimeter (mm) scale (0= no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 20. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 1 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 2 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Last Observation Carried Forward (LOCF): Period 3 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 1 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 2 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society 40 (ASAS 40) Response: Observed Cases (OC): Period 3 | ASAS measures symptomatic improvement in AS in 4 domains: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). ASAS 40 responders were defined as participants with at least 40% and absolute improvement of at least 2 units on a 0 to 10 cm scale (converted from 0 to 100 mm) or an improvement of 100% for those domains that have a baseline score <2 in at least 3 of the 4 domains: participant assessment of disease activity, mean of participants assessment of total back pain, function represented by the BASFI score, inflammation represented by the mean of the two morning stiffness-related BASDAI scores. No worsening at all in any of the domains. Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). These scores were then converted to 0-10 cm scale for assessment of ASAS 40. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 1 | ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 2 | ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Last Observation Carried Forward (LOCF): Period 3 | ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 1 | ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 2 | ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Assessment of Spondyloarthritis Society (ASAS) Partial Remission: Observed Cases (OC): Period 3 | ASAS partial remission was defined as a score of 2 units or less (on a scale of 0-10 cm, where 0 = no disease activity and 10 = high disease activity) in each of the 4 domains of ASAS: participant global assessment of disease activity, total back pain, function (from BASFI) and inflammation (from BASDAI). Each domain was measured on a 0-100 mm scale (0=no disease activity; 100 = high disease activity, where higher scores indicated higher disease activity). Reported values were then converted into cm for analysis. | Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 1 | ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 2 | ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm,where 0= no disease activity and 10= high disease activity.CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Last Observation Carried Forward (LOCF): Period 3 | ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3: Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 1 | ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 2 | ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Score: Observed Cases (OC): Period 3 | ASDAS: score combining assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on VAS ranging 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS ranged as inactive disease: 0<= ASDAS-CRP <1.3; moderate disease activity: 1.3<= ASDAS-CRP <2.1; high disease activity: 2.1<= ASDAS-CRP <=3.5; very high disease activity: 3.5< ASDAS-CRP. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 1 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 2 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Last Observation Carried Forward (LOCF): Period 3 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 1 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 2 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)-Erythrocyte Sedimentation Rate (ESR) Score: Observed Cases (OC): Period 3 | ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0 = no disease activity and 100= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. ASDAS-ESR was calculated with the following equation: 0.8*total back pain+0.11*participant global+0.09*peripheral pain/swelling+0.07*duration of morning stiffness+ 0.29*ESR^1/2. ASDAS ranged as inactive disease: 0 <= ASDAS-ESR <1.3; active disease: 1.3 <= ASDAS-ESR =<2.1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 1 | Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 2 | Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Last Observation Carried Forward (LOCF): Period 3 | Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 1 | Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 2 | Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Major Improvement: Observed Cases (OC): Period 3 | Major improvement in ASDAS-CRP was defined as decrease from baseline >= 2.0 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110*participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln(CRP+1), Ln represents the natural logarithm. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 1 | ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 2 | ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Last Observation Carried Forward (LOCF): Period 3 | ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm. | Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 1 | ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm. | Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 2 | ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm. | Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved Ankylosing Spondylitis Disease Activity Score (ASDAS) C-Reactive Protein (CRP) Clinically Important Improvement: Observed Cases (OC): Period 3 | ASDAS-CRP clinically important improvement was defined as a decrease from baseline of >=1.1 units. ASDAS is a score combining the assessment of back pain, peripheral pain/swelling, duration of morning stiffness, participant global assessment of disease activity and CRP or ESR. All parameters other than CRP or ESR assessed on a VAS ranging from 0-10 cm, where 0= no disease activity and 10= high disease activity. CRP measured in mg/L and ESR measured in mm/hr. The ASDAS-CRP is calculated with the following equation: 0.121*total back pain+0.110* participant global+0.073*peripheral pain/swelling+0.058*duration of morning stiffness+0.579*Ln (CRP+1), Ln represents the natural logarithm. | Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 1 | Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to centimeter (cm) for analysis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 2 | Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Nocturnal Back Pain: Last Observation Carried Forward (LOCF): Period 3 | Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 1 | Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 2 | Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Nocturnal Back Pain: Observed Cases (OC): Period 3 | Participants assessed their nocturnal back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 1 | Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 2 | Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Total Back Pain: Last Observation Carried Forward (LOCF): Period 3 | Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Total Back Pain: Observed Cases (OC): Period 1 | Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Total Back Pain: Observed Cases (OC): Period 2 | Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Total Back Pain: Observed Cases (OC): Period 3 | Participants assessed their total back pain over the last 48 hours on a 100 mm VAS scale ranged from 0 mm (none) to 100 mm (severe), where higher scores indicated more pain. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 1 | BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 2 | BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Observed Cases (OC): Period 3 | BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 1 | BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 2 | BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI): Last Observation Carried Forward (LOCF): Period 3 | BASFI is composed of 10 questions related to the participant's ability to function. Each question scored by the participant on a 100 mm scale ranging from 0 (easy) to 100 (impossible), where higher scores indicated more difficulty in participant's ability to function. The BASFI total score calculated as mean of the scores for these 10 questions and converted to cm for analysis. BASFI total score was ranged from 0 (easy) to 10 (impossible), where higher scores indicated more difficulty in participant's ability to function due to ankylosing spondylitis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 1 | BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 2 | BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Observed Cases (OC): Period 3 | BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 1 | BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score:Last Observation Carried Forward (LOCF): Period 2 | BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Mean Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Total Score: Last Observation Carried Forward (LOCF): Period 3 | BASDAI consisted of 6 questions related to disease activity. Each of the first 5 questions was scored by the participant on a 100 mm scale ranging from 0 (none) to 100 (very severe), where higher scores indicated more severe disease activity. The sixth question, related to duration of morning stiffness measured on a scale for 0 (0 hours) to 100 (2 hours), where higher scores indicated larger duration of morning stiffness. The BASDAI score was obtained by computing the mean score for the 2 questions related to morning stiffness (questions 5 [severity of morning stiffness] and 6 [duration of morning stiffness]) and then adding that value to the sum of the scores for the first 4 questions and then dividing the total by 5. This can be written as BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. The BASDAI total score ranged from 0 to 10, where higher scores indicated more severe disease activity. The reported values were converted to cm for analysis. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 1 | 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1). | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 2 | 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal). | Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI): Observed Cases (OC): Period 3 | 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment). | Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 1 | 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. Improvement was relative to baseline (Day 1). | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 2 | 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 2 baseline(last visit before treatment withdrawal). | Period 2 baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Percentage of Participants Who Achieved at Least 50% Improvement From Baseline in Disease Activity According to Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) :Last Observation Carried Forward (LOCF): Period 3 | 50% improvement from baseline in BASDAI: percentage of participants who achieved 50% decrease from baseline in their BASDAI total score. BASDAI consisted: 6 questions (Q) related to disease activity. Each of first 5 questions was scored by participant on 100 mm scale, range 0=none to 100=very severe, higher scores = more severe disease activity. Sixth question: duration of morning stiffness, was on scale for 0=0 hours to 100=2 hours, higher scores = larger duration of morning stiffness. BASDAI score was obtained by computing mean score for 2 questions related to morning stiffness (Q5 [severity of morning stiffness], Q6 [duration of morning stiffness]) and adding that value to sum of the scores for first 4Q and then dividing total by 5. BASDAI=(Q1+Q2+Q3+Q4+(Q5+Q6)/2)/5. BASDAI total score ranged from 0 to 10, higher scores = more severe disease activity. Reported values were converted to cm for analysis. The improvement was relative to period 3 baseline (last visit before retreatment). | Period 3 baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 1 | Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 2 | Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Observed Cases (OC): Period 3 | Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 1 | Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 2 | Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Mean Change From Baseline in Highly Sensitive C Reactive Protein (hsCRP): Last Observation Carried Forward (LOCF): Period 3 | Change from baseline in hsCRP levels were reported. hsCRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Observed Cases (OC): Period 1 | The EQ-5D questionnaire is a health-related quality of life assessment (HRQOL). The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. The outcome measure was planned to be analyzed at baseline, Week 12 and 24. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Observed Cases (OC): Period 2 | The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. | Week 32, 48, 64 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Observed Cases (OC): Period 3 | The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. | Week 64, 76 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. This outcome measure was planned to be analyzed at baseline, Week 12 and 24. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. | Week 32, 48, 64 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) VAS Score > 82 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | The EQ-5D questionnaire is a HRQOL. The EQ-5D questionnaire assesses HRQOL in terms of degree of limitation on 5 health dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) and as overall health using a VAS with response options. Overall EQ 5D VAS score ranged from 0 (worst imaginable health) to 100 (best imaginable health). Lower scores indicate worsening. In this outcome measure, data for percentage of participants who reached the cut-off value of > 82 is reported. This threshold was based on participant's demographic characteristics and population norm. | Week 64, 76 | |
| Secondary | Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Observed Cases (OC): Period 1 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24. | Week 12, 24 | |
| Secondary | Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Observed Cases (OC): Period 2 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 32, 48, 64 | |
| Secondary | Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Observed Cases (OC): Period 3 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 64, 76 | |
| Secondary | Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24. | Week 12, 24 | |
| Secondary | Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 32, 48, 64 | |
| Secondary | Percentage of Participants With >=0.05 Score Increase From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 64, 76 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Observed Cases (OC): Period 1 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Observed Cases (OC): Period 2 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 32, 48, 64 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Observed Cases (OC): Period 3 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 64, 76 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. This outcome measure was planned to be analyzed at baseline, Week 12 and 24. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 32, 48, 64 | |
| Secondary | Percentage of Participants Who Achieved an European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Score of 1 at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Week 64, 76 | |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Observed Cases (OC): Period 1 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Observed Cases (OC): Period 2 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Observed Cases (OC): Period 3 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in European Quality of Life-5 Dimensions Health Questionnaire (EQ-5D) Index Scores at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | The EuroQol-5D is a five dimensional health state classification. Each dimension is assessed on a 3-point ordinal scale (1=no problems, 2=some problems, 3=severe problems). The responses to the five EQ-5D dimensions were scored using a utility-weighted algorithm to derive an EQ-5D health status index score between 0 to 1, with 1.00 indicating "no problem" and 0 representing ''worst health condition''. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 12, 24: Observed Cases (OC): Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores (physical component scores [PCS]; mental component scores [MCS]). Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Observed Cases (OC): Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Observed Cases (OC): Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Physical Component Score (PCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal). | Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment). | Period 3 baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 12, 24: Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 32, 48, 64: Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal). | Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Physical Component Score at Week 64, 76: Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment). | Period 3 baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Observed Cases (OC): Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Observed Cases (OC): Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Observed Cases (OC): Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to baseline (Day 1). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal). | Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Percentage of Participants With >=2.5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment). | Period 3 baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 12, 24: Period 1 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). The improvement was relative to baseline (Day 1). | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 32, 48, 64: Period 2 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 2 baseline (last visit before treatment withdrawal). | Period 2 baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Percentage of Participants With >=5 Score Improvement From Baseline in Short Form-36 (SF-36) Mental Component Score (MCS) at Week 64, 76: Period 3 | SF-36 is widely used generic quality of life instrument that assesses the participant's general health and functional status. SF-36 consists of 36 questions that grouped into 8 domains (physical functioning, vitality, social functioning, mental health, role physical, bodily pain, role emotional and general health). Domain scores range from 0 (worst value) to 100 (best value), with greater scores reflecting better health status. Scores of 8 health aspects were summarized to derive the 2 component scores: PCS, MCS. Four domains of the SF-36 comprises the PCS score (physical functioning, role-physical, bodily pain, and general health) and remaining 4 domains comprises of the MCS score (vitality, social functioning, role-emotional, and mental health). Each PCS and MCS are scored from 0 to 100 with higher scores indicating better health (0= worst value and 100= best value). Improvement was relative to period 3 baseline (last visit before retreatment). | Period 3 baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 1 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "ankylosing spondylitis (AS)" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 2 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Observed Cases (OC): Period 3 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 1 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 2 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Work Productivity and Activity Impairment (WPAI): Last Observation Carried Forward (LOCF): Period 3 | The WPAI assesses work productivity and impairment. It is a 6-item questionnaire used to assess the degree to which a specified health problem here "AS" affected work attendance, work productivity and productivity in non-work regular activities. Participants were asked to consider the past 7 days prior to each questionnaire day. The questionnaire asks: current employment status, hours worked, hours missed from work for any reason other than AS, hours missed from work due to AS, degree to which AS affected work productivity, and degree to a which AS affected non-work regular activities. Four component scores were then calculated: percent work time missed due to AS; percent impairment while working due to AS, percent overall work impairment due to AS, and percent non-work activity impairment due to AS. The computed percentage range for each sub-scale was from 0-100, with higher numbers indicating greater impairment and less productivity. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Last Observation Carried Forward (LOCF): Period 1 | Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease. | Baseline (Day 1 Week 1), Week 24 | |
| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Last Observation Carried Forward (LOCF): Period 2 | Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64 | |
| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 24: Observed Cases (OC): Period 1 | Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease. | Baseline (Day 1 Week 1), Week 24 | |
| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 48, 64: Observed Cases (OC): Period 2 | Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 48, 64 | |
| Secondary | Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score) at Week 64, 76: Observed Cases (OC): Period 3 | Change from baseline in MRI score of spine was assessed using SPARCC method. Scoring was based on 6 consecutive coronal slices from posterior to anterior. Each joint was divided into 4 quadrants. Each quadrant was assigned score of 0=no lesion or 1=increased signal. This part of coring allows for total score ranging from 0-8 for the 2 joints of one coronal slice. For each slice, score was increased by 1 for each joint that exhibits an intense signal in any quadrant (thereby allowing for an increase of up to 2 points in total score for each slice). Also, for each slice, an additional score of 1 was given for each joint that includes a lesion demonstrating continuous increased signal of depth >=1 cm from articular surface (thereby allowing for an additional increase of up to 2 points for each slice). The total minimum and maximum score for all joints across 6 slices was 0 to 72 where higher scores reflecting worse disease. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Time to Ankylosing Spondylitis Disease Activity Score (ASDAS) Inactive Disease After Re-treatment in Period 3 | Time to ASDAS inactive disease was defined as the time from first dose of retreatment until the first observed event of ASDAS inactive disease. Inactive disease is defined as an ASDAS score <1.3. for ASDAS-CRP or ASDAS score of >=2.1 for ASDAS-ESR. Participants who did not achieve ASDAS inactive disease were censored at the time of the last ASDAS evaluation in the interval. | Within 12 weeks of Period 3 (retreatment period from Week 64 to 76) | |
| Secondary | Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1 | Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2 | Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3 | Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1 | Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2 | Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Subject Assessment of Disease Activity (SADA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3 | Participants assessed their overall disease activity over the last 48 hours by using a 100 mm pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 1 | The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 2 | The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Observed Cases (OC): Period 3 | The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 1 | The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Baseline (Day 1 Week 1), Week 4, 8, 12, 16, 24 | |
| Secondary | Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 2 | The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 28, 32, 40, 48, 56, 64 | |
| Secondary | Change From Baseline in Physician Global Assessment (PGA) Visual Analogue Scale (VAS): Last Observation Carried Forward (LOCF): Period 3 | The physician assessed the overall disease activity of participants over the last 48 hours by using a 100 mm VAS pain scale that ranges from 0 mm (none) to 100 mm (severe pain), where higher scores indicated more pain. The reported values then converted to cm for analysis purposes. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 68, 72, 76 | |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 12, 24: Observed Cases (OC): Period 1 | The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score) at Week 32, 48, 64: Observed Cases (OC): Period 2 | The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Bath Ankylosing Spondylitis Global Index (BAS-G) Score at Week 64, 76: Observed Cases (OC): Period 3 | The BAS-G was a 2-question assessment evaluating the effect of AS on the participants well-being over the last week and last 6 months. Each question scored by the participant on a 100 mm VAS scale ranging from 0 (very Good) to 100 (very Bad), where higher scores indicated worse health condition. The total BAS-G score calculated as the average scores of these two questions and then converted into cm for analysis. Total BAS-G score ranged from 0 to 10 cm, where higher scores indicated worse health condition. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Observed Cases (OC): Period 1 | Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2 | Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Number of Swollen Joint Count at Week 64, 76: Observed Cases (OC): Period 3 | Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Number of Swollen Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Number of Swollen Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Number of Swollen Joint Count at Week 64, 76 : Last Observation Carried Forward (LOCF): Period 3 | Number of swollen joints was determined by examination of 44 joints and identifying when swelling was present. The number of swollen joints was recorded on the joint assessment form at each visit, no swelling =0, swelling =1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Number of Tender Joint Count at Week 12, 24: Observed Cases (OC): Period 1 | Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Observed Cases (OC): Period 2 | Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Number of Tender Joint Count at Week 64, 76: : Observed Cases (OC): Period 3 | Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Number of Tender Joint Count at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Number of Tender Joint Count at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Number of Tender Joint Count at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | Number of tender joints was determined by examining 44 joints and identified the joints that were painful under pressure or to passive motion. The number of tender joints was recorded on the joint assessment form at each visit, no tenderness = 0, tenderness = 1. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Dactylitis Total Score at Week 12, 24: Observed Cases (OC): Period 1 | Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Observed Cases (OC): Period 2 | Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Dactylitis Total Score at Week 64, 76: Observed Cases (OC): Period 3 | Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Dactylitis Total Score at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Dactylitis Total Score at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Dactylitis Total Score at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | Dactylitis is the inflammation of finger and/or toe joints (digits). Dactylitis scores was calculated by evaluating each of the 10 fingers and 10 toes. Each digit was evaluated on a 4-point scale ranging from of 0 to 3 where 0 = none, 1= mild, 2 = moderate, 3 = severe inflammation. The total score was calculated as the sum of scores for the 20 digits, total score ranged from 0 to 60, where higher scores indicated severe inflammation. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Observed Cases (OC) : Period 1 | The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Observed Cases (OC): Period 2 | The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Observed Cases (OC): Period 3 | The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 12, 24: Last Observation Carried Forward (LOCF): Period 1 | The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses. | Baseline (Day 1 Week 1), Week 12, 24 | |
| Secondary | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 32, 48, 64: Last Observation Carried Forward (LOCF): Period 2 | The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses. | Period 1 Baseline (Day 1 Week 1), Period 2: Baseline (last visit before treatment withdrawal), Week 32, 48, 64 | |
| Secondary | Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) at Week 64, 76: Last Observation Carried Forward (LOCF): Period 3 | The MASES is an index used to measure the severity of enthesitis. Enthesitis is the inflammation of enthuses (heels). The MASES assesses 13 sites for enthesitis. Each site is scored as 0 or 1 depending on whether enthesitis is present or absent. Sites assessed include 1st costochondral joint (left/right), 7 th costochondral joint (l/r), posterior superior iliac spine (l/r), posterior anterior iliac spine (l/r), iliac crest (l/r), proximal insertion of Achilles tendon (l/r) and 5th lumbar spinous process. The MASES is the sum of all site scores range from 0 (no inflammation) to 13 (worst possible inflammation) where higher scores indicate more severe inflammation of entheses. | Period 1 Baseline (Day 1 Week 1), Period 2 Baseline (last visit before treatment withdrawal), Period 3 Baseline (last visit before retreatment), Week 64, 76 | |
| Secondary | Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received investigational product without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically important events. Treatment-emergent were events between first dose of investigational product and up to 28 days after the last dose of investigational product that were absent before treatment or that worsened relative to pretreatment state. | Baseline (Day 1) up to 28 days after last dose of study drug (for period 1: maximum up to 28 weeks, for period 2: maximum up to 68 weeks, period 3: maximum up to 80 weeks) |
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