Spondyloarthropathies Clinical Trial
Official title:
Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of Certolizumab Pegol in Subjects With Active Axial Spondyloarthritis
Verified date | November 2016 |
Source | UCB Pharma |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The study is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of two dose regimens of Certolizumab Pegol (CZP) in subjects with active axial Spondyloarthritis (axial SpA).
Status | Completed |
Enrollment | 325 |
Est. completion date | August 2015 |
Est. primary completion date | October 2011 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Documented diagnosis of adult-onset axial Spondyloarthritis (SpA) of at least 3 months' duration as defined by the specified Assessment of Spondyloarthritis International Society (ASAS) criteria - Active disease as defined by: - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score = 4 - Back pain = 4 on a 0 to 10 Neurobehavioral Rating Scale (NRS) (from BASDAI item 2) - C-Reactive Protein (CRP) > ULN (Upper Limit of Normal) and/or current evidence (ie, within the last 3 months from Screening) for Sacroiliitis on Magnetic Resonance Imaging (MRI) as defined by Assessment of Spondyloarthritis International Society (ASAS) criteria - Intolerance to or inadequate response to at least 1 Nonsteroidal Anti-Inflammatory Drug (NSAID) Exclusion Criteria: - Presence of total Spinal Ankylosis ("bamboo spine") - Diagnosis of any other Inflammatory Arthritis - Prior treatment with any experimental biological agents for treatment of Axial Spondyloarthritis (SpA) - Exposure to more than 1 TNF-antagonist or to more than 2 previous biological agents for Axial Spondyloarthritis (SpA) - History of or current chronic or recurrent infections - High risk of infection - Recent live vaccination - Concurrent malignancy or a history of malignancy - Class III or IV congestive heart failure - New York Heart Association (NYHA) - Demyelinating disease of the central nervous system - Female subjects who are breastfeeding, pregnant or plan to become pregnant during the study or within 3 months following the last dose of the investigational product - Subjects with any other condition which, in the investigator's judgment, would make the subject unsuitable for inclusion in the study |
Country | Name | City | State |
---|---|---|---|
Argentina | 700 | Buenos Aires | |
Argentina | 701 | Buenos Aires | |
Argentina | 704 | Buenos Aires | |
Argentina | 705 | Cordoba | |
Argentina | 709 | La Plata | |
Argentina | 706 | Rosario | |
Argentina | 710 | San Juan | |
Argentina | 702 | San Miguel de Tucuman | |
Argentina | 708 | San Miguel de Tucuman | |
Belgium | 153 | Brussels | |
Belgium | 152 | Gent | |
Belgium | 151 | Liege | |
Brazil | 760 | Campinas | |
Brazil | 750 | Curitiba | |
Brazil | 761 | Goiânia | |
Brazil | 756 | Sao Paulo | |
Canada | 902 | Sainte Foy | Quebec |
Canada | 900 | St. John's | Newfoundland and Labrador |
Canada | 907 | Victoria | British Columbia |
Canada | 910 | Windsor | Ontario |
Canada | 903 | Winnipeg | Manitoba |
Czechia | 504 | Brno | |
Czechia | 501 | Hlucin | |
Czechia | 500 | Pardubice | |
Czechia | 502 | Praha 2 | |
Czechia | 505 | Terezin | |
Czechia | 503 | Zlin | |
France | 200 | Boulogne-Billan Court | |
France | 201 | Lille | |
France | 205 | Limoges | |
France | 206 | Montpellier | |
France | 204 | Paris | |
France | 202 | Tours | |
Germany | 257 | Berlin | |
Germany | 258 | Berlin | |
Germany | 255 | Freiburg | |
Germany | 254 | Hamburg | |
Germany | 250 | Herne | |
Germany | 253 | Leipzig | |
Germany | 260 | München | |
Germany | 263 | München | |
Germany | 256 | Ratingen | |
Hungary | 303 | Budapest | |
Hungary | 305 | Budapest | |
Hungary | 302 | Debrecen | |
Hungary | 306 | Miskolc | |
Hungary | 300 | Veszprém | |
Italy | 352 | Ancona | |
Italy | 351 | Firenze | |
Italy | 350 | Pisa | |
Mexico | 802 | Cuernavaca | |
Mexico | 801 | Monterrey | |
Netherlands | 401 | Maastricht | |
Netherlands | 400 | Rotterdam | |
Poland | 458 | Bialystok | |
Poland | 452 | Dabrowka | |
Poland | 455 | Elblag | |
Poland | 459 | Gdanks | |
Poland | 457 | Krakow | |
Poland | 450 | Lublin | |
Poland | 454 | Poznan | |
Poland | 453 | Torun | |
Poland | 456 | Warszawa | |
Poland | 462 | Warszawa | |
Spain | 550 | Mérida | |
Spain | 554 | Santander | |
Spain | 552 | Santiago de Compostela | |
Spain | 553 | Sevilla | |
United Kingdom | 605 | Barnsley | |
United Kingdom | 600 | Leeds | |
United Kingdom | 602 | London | |
United Kingdom | 601 | Salford | |
United States | 963 | Asheville | North Carolina |
United States | 957 | Aventura | Florida |
United States | 961 | Birmingham | Alabama |
United States | 985 | Brooklyn | New York |
United States | 977 | Cleveland | Ohio |
United States | 975 | Dallas | Texas |
United States | 972 | Duncansville | Pennsylvania |
United States | 969 | Eagan | Minnesota |
United States | 965 | Florissant | Missouri |
United States | 984 | Flowood | Mississippi |
United States | 962 | Fort Lauderdale | Florida |
United States | 964 | Hagerstown | Maryland |
United States | 978 | Houston | Texas |
United States | 983 | Houston | Texas |
United States | 974 | La Jolla | California |
United States | 973 | Los Angeles | California |
United States | 951 | Middleburg Heights | Ohio |
United States | 970 | Oklahoma City | Oklahoma |
United States | 959 | Orange Park | Florida |
United States | 966 | Palm Desert | California |
United States | 954 | Peoria | Arizona |
United States | 990 | Pinellas Park | Florida |
United States | 982 | Portland | Oregon |
United States | 950 | Saint Louis | Missouri |
United States | 981 | Salt Lake City | Utah |
United States | 967 | San Antonio | Texas |
United States | 952 | San Diego | California |
United States | 971 | Scottsdale | Arizona |
United States | 968 | Seattle | Washington |
United States | 987 | Tucson | Arizona |
United States | 953 | Tuscaloosa | Alabama |
United States | 958 | Vero Beach | Florida |
Lead Sponsor | Collaborator |
---|---|
UCB BIOSCIENCES GmbH |
United States, Argentina, Belgium, Brazil, Canada, Czechia, France, Germany, Hungary, Italy, Mexico, Netherlands, Poland, Spain, United Kingdom,
Landewé R, Braun J, Deodhar A, Dougados M, Maksymowych WP, Mease PJ, Reveille JD, Rudwaleit M, van der Heijde D, Stach C, Hoepken B, Fichtner A, Coteur G, de Longueville M, Sieper J. Efficacy of certolizumab pegol on signs and symptoms of axial spondyloar — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 12 | The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: Patient's Global Assessment of Disease Activity Pain assessment (total spinal pain) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit). |
Week 12 | |
Secondary | Assessment in Axial Spondyloarthritis International Society 20 % (ASAS20) Response Criteria at Week 24 | The ASAS20 is defined as an improvement of at least 20 % and absolute improvement of at least 1 unit on a 0 to 10 Numeric Rating Scale (NRS) in at least 3 of the 4 following domains: Patient's Global Assessment of Disease Activity Pain assessment (total spinal pain) Function (represented by Bath Ankylosing Spondylitis Functional Index (BASFI)) Inflammation (the mean of the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) questions 5 and 6 concerning morning stiffness intensity and duration) and absence of deterioration in the potential remaining domain (deterioration is defined as a relative worsening of at least 20 % and an absolute worsening of at least 1 unit). |
Week 24 | |
Secondary | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 12 | The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline to Week 12 | |
Secondary | Change From Baseline in the Bath Ankylosing Spondylitis Functional Index (BASFI) at Week 24 | The BASFI assesses physical function in comprising 10 items relating to activities during the past week. Each item ranges from 0 ("Easy") to 10 ("Impossible"). The BASFI is the mean of the 10 scores such that the total score ranges from 0 to 10, with lower scores indicating better physical function. A negative value in BASFI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline to Week 24 | |
Secondary | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 12 | The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline to Week 12 | |
Secondary | Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 24 | The BASDAI is a validated self-reported instrument which consists of six 10 unit horizontal Numerical Rating Scales (NRSs) to measure severity of fatigue, spinal and peripheral joint pain and swelling, enthesitis, and morning stiffness (both severity and duration, respectively) over the last week. The final BASDAI score ranges from 0 to 10, with lower scores indicating lower disease activity. A negative value in BASDAI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline to Week 24 | |
Secondary | Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 12 | The BASMI characterizes the spinal mobility of subjects with axial Spondyloarthritis (SpA) and Ankylosing Spondylitis (AS). It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline to Week 12 | |
Secondary | Change From Baseline in the Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 24 | The BASMI characterizes the spinal mobility of subjects with axial SpA and AS. It is a disease-specific measure consisting of 5 clinical measures to reflect subject axial status: cervical rotation; tragus to wall distance; lateral lumbar flexion; lumbar flexion (modified Schober test); intermalleolar distance. According to the linear definition of the BASMI a score of 0 to 10 is calculated for each item based on the measurement. The mean of the sum of the 5 scores provides the BASMI score. The higher the BASMI score the more severe the patient's limitation of movement due to their axial SpA. A negative value in BASMI change from Baseline indicates an improvement from Baseline. The higher the negative value the better the improvement. | From Baseline to Week 24 | |
Secondary | Change From Baseline in the Spine Ankylosing Spondylitis Spine Magnetic Resonance Imaging (MRI) Scoring System for Disease Activity (ASspiMRI-a) in the Berlin Modification at Week 12 | The Berlin modification of the ASspiMRI-a is a scoring system with a concentration on Short-Tau-Inversion Recovery (STIR) sequences without other fat saturation techniques. It quantifies changes in 23 Vertebral Units (VU) of the spine. A VU is defined as the region between 2 virtual lines through the middle of each vertebra. Active inflammation is scored by grading the degree of bone marrow edema from 0 to 3 in 1 dimension on 1 or more consecutive slices that represent the highest level of inflammation in a particular VU. Total spine ASspiMRI-a score in the Berlin modification can range from 0 to 69 with higher scores indicating higher disease activity. A negative value in total spine ASspiMRI-a score change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation. | From Baseline to Week 12 | |
Secondary | Change From Baseline in Sacroiliac Spondyloarthritis Research Consortium of Canada (SPARCC) Score at Week 12 | The SPARCC scoring method for lesions found on the Magnetic Resonance Imaging (MRI) is based on an abnormal increased signal on the Short-Tau-Inversion Recovery (STIR) sequence, representing bone marrow edema. Total Sacroiliac (SI) joint SPARCC score can range from 0 to 72 with higher scores indicating higher joint inflammation. A negative value in SPARCC change from Baseline indicates an improvement from Baseline. The higher the negative value the higher the reduction of inflammation. | From Baseline to Week 12 |
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