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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03129100
Other study ID # 16181
Secondary ID I1F-MC-RHBY2016-
Status Completed
Phase Phase 3
First received
Last updated
Start date May 9, 2017
Est. completion date May 27, 2021

Study information

Verified date May 2022
Source Eli Lilly and Company
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate, in participants having achieved a state of sustained remission, if the ixekizumab treatment groups are superior to the placebo group in maintaining response during the randomized withdrawal-retreatment period in participants with axial spondyloarthritis.


Recruitment information / eligibility

Status Completed
Enrollment 773
Est. completion date May 27, 2021
Est. primary completion date May 26, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352). (Note: Participants from Study RHBX are not eligible if they permanently discontinued ixekizumab and were receiving a tumor necrosis factor [TNF] inhibitor). - Must agree to use a reliable method of birth control. Exclusion Criteria: - Have significant uncontrolled disorders or abnormal laboratory values that, in the opinion of the investigator, pose an unacceptable risk to the participant if investigational product continues to be administered. - Have a known hypersensitivity to ixekizumab or any component of this investigational product. - Had investigational product permanently discontinued during a previous ixekizumab study. - Had temporary investigational product interruption at any time during or at the final study visit of a previous ixekizumab study and, in the opinion of the investigator, restarting ixekizumab poses an unacceptable risk for the participant's participation in the study. - Have any other condition that, in the opinion of the investigator, renders the participant unable to understand the nature, scope, and possible consequences of the study or precludes the participant from following and completing the protocol. - Are currently enrolled in any other clinical trial involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ixekizumab
Administered SC
Placebo
Administered SC

Locations

Country Name City State
Argentina Consultorios Reumatologicos Pampa Ciudad Autonoma de Buenos Aire
Argentina Clinica Adventista de Belgrano Ciudad de Buenos Aires Buenos Aires
Argentina CER Instituto Medico Quilmes Buenos Aires
Argentina Centro de Enfermedades del Higado y Aparato Digestivo Rosario Santa Fe
Argentina Centro Medico Privado de Reumatologia San Miguel de Tucuman Tucuman
Argentina CIR Centro de Investigacions Reumatologicas San Miguel de Tucuman
Austria KH der Barmherzigen Schwestern Wien BetriebsGesmbH Wien
Brazil EDUMED - Educação em Saúde Ltda. Curitiba Paraná
Brazil CIP - Centro Internacional de Pesquisa Goiás
Brazil CMIP - Centro Mineiro de Pesquisa Juiz de Fora Minas Gerais
Brazil Hospital de Clinicas de Porto Alegre Porto Alegre RS
Brazil LMK Serviços Médicos S/S Porto Alegre Rio Grande Do Sul
Brazil CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA Rio de Janeiro RJ
Brazil Cpclin Centro de Pesquisas Clinicas Sao Paulo São Paulo
Canada University of Alberta Hospital Edmonton Alberta
Canada Group de recherche en maladies osseuses Quebec
Canada St. Clare's Mercy Hospital St. John's Newfoundland and Labrador
Canada Centre de Recherche Musculo-Squelettique Trois-Rivieres Quebec
Czechia Revmaclinic, s.r.o Brno
Czechia Interni a revmatologicka ambulance, Inrea s.r.o. Ostrava
Czechia Arthrohelp s.r.o Pardubice
Czechia Revmatologicky ustav Praha 2
Czechia MEDICAL PLUS, s.r.o. Uherske Hradiste
Finland Helsinki University Hospital, HYKS Helsinki
Finland Terveystalo Kamppi Helsinki
Finland Kiljava Medical Research Hyvinkaa
France Hôpital Trousseau, CHRU de Tours Chambray-lès-Tours
France Centre hospitalier universitaire Lapeyronie Montpellier Cedex 5
France Nouvel Hôpital Orléans La Source Orleans CEDEX 2
Germany Rheumazentrum Prof. Neeck Bad Doberan Mecklenburg-Vorpommern
Germany Charité Universitätsmedizin Berlin Berlin
Germany HRF Hamburger Rheuma Forschungszentrum Hamburg
Germany Rheumazentrum Ruhrgebiet Herne Nordrhein-Westfalen
Hungary Revita Reumatologiai Kft. Budapest
Hungary Vital Medical Center Veszprem
Israel Barzilai Medical Center Ashkelon
Israel Rambam Medical Center Haifa
Israel Rabin Medical Center Petach Tikva
Israel Tel Aviv Sourasky Medical Center Tel Aviv
Italy Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia Reggio Emilia
Japan Juntendo University Hospital Bunkyo-ku Tokyo
Japan St. Lukes International Hospital Chuo-Ku Tokyo
Japan Kagawa University Hospital Kita-gun Kagawa
Japan Kuwana City Medical Center Kuwana Mie
Japan Kochi Medical School Hospital Nankoku Kochi
Japan Japanese Red Cross Okayama Hospital Okayama
Japan Osaka City General Hospital Osaka
Japan Osaka City University Hospital Osaka
Japan Hokkaido University Hospital Sapporo Hokkaido
Japan Sasebo Chuo Hospital Sasebo Nagasaki
Japan Osaka University Hospital Suita-shi Osaka
Japan Yamagata University Hospital Yamagata
Korea, Republic of Chungnam National University Hospital Daejeon
Korea, Republic of Gangnam Severance Hospital Seoul
Korea, Republic of Hanyang University Medical Center Seoul
Korea, Republic of Konkuk University Hospital Seoul
Korea, Republic of Kyung Hee University Hospital Seoul Korea
Korea, Republic of Kyunghee University Hospital at Gangdong Seoul
Korea, Republic of Seoul Municipal Boramae Hospital Seoul
Korea, Republic of Seoul National University Hospital Seoul
Korea, Republic of Seoul St. Mary's Hospital Seoul Korea
Korea, Republic of Asan Medical Center Songpa-gu Seoul
Mexico Investigación y Biomedicina de Chihuahua, SC Chihuahua
Mexico Clinica en Investigación en Reumatologia y Obesidad S.C. Guadalajara Jalisco
Mexico Unidad de Investigacion en Enfermedades Cronico Degenerative Guadalajara Jalisco
Mexico Medical Care and Research, S.A. de C.V. Merida Yucatan
Mexico Ctro Inv en Artritis y Osteoporosis SC Mexicali Baja California
Mexico Hospital Universitario de Monterrey Monterrey Nuevo Leon
Mexico Centro de Alta Especialidad Reumatologia Inv del Potosi SC San Luis Potosi SLP
Netherlands Academisch Medisch Centrum Amsterdam
Netherlands Antonius Ziekenhuis Sneek
Poland NZOZ ZDROWIE Osteo-Medic Bialystok
Poland Szpital Uniwersytecki nr 2 im. dr J. Biziela Bydgoszcz
Poland Centrum Kliniczno-Badawcze Elblag
Poland Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci Lodz
Poland Lecznica MAK-MED, NZOZ Nadarzyn
Poland Prywatna Praktyka Lekarska P. Hrycaj Poznan
Poland Lubelskie Centrum Diagnostyczne Swidnik
Poland Centrum Medyczne AMED Warszawa
Poland Reumatika Centrum Reumatologii Warszawa
Puerto Rico GCM Medical Group PSC San Juan
Puerto Rico Latin Clinical Trial Center San Juan
Puerto Rico Mindful Medical Research San Juan
Romania Spitalul Clinic Sf Maria Bucuresti Bucuresti
Romania Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta Constanta
Russian Federation City Clinical Hospital N1 Moscow
Russian Federation V.A. Nasonova Research Institute of Rheumatology Moscow
Russian Federation Ryazan Regional Clinincal Cardiology Dispensary Ryazan
Russian Federation Saratov State Medical University Saratov
Russian Federation Clinical Rheumatology Hospital # 25 St. Petersburg
Russian Federation Clinical Hospital for Emergency Care Yaroslavl
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Centro de Salud Mental Parc Tauli Sabadell Barcelona
Spain Hospital Infanta Luisa Sevilla
Taiwan Chang Gung Memorial Hospital - Kaohsiung Kaohsiung
Taiwan China Medical University Hospital Taichung
Taiwan Chung Shan Medical University Hospital Taichung City
Taiwan National Taiwan University Hospital Taipei
Taiwan Chi-Mei Medical Center Yongkang City
United Kingdom Norfolk and Norwich Hospital Norwich Norfolk
United Kingdom Solihull Hospital Solihull West Midland
United Kingdom Haywood Hospital Stoke on Trent Staffordshire
United Kingdom New Cross Hospital Wolverhampton West Midlands
United Kingdom Wythenshawe Hospital Wythenshawe Manchester
United States Arthritis Rheumatic Disease Specialties Aventura Florida
United States Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC Colorado Springs Colorado
United States Articularis Healthcare Group, INC dba Columbia Arthritis Ctr Columbia South Carolina
United States Klein and Associates MD, PA Cumberland Maryland
United States Clinical Research Center of CT/NY Danbury Connecticut
United States Altoona Center for Clinical Research Duncansville Pennsylvania
United States Center for Arthritis & Osteoporosis Elizabethtown Kentucky
United States Klein and Associates MD, PA Hagerstown Maryland
United States Univ of Texas Health Science Center - Houston Houston Texas
United States Care Access Research - Huntington Beach Huntington Beach California
United States Institute of Arthritis Research Idaho Falls Idaho
United States Glacier View Research Institute Kalispell Montana
United States Physician Research Collaboration, LLC Lincoln Nebraska
United States Marietta Rheumatology Marietta Georgia
United States Desert Medical Advances Palm Desert California
United States Arizona Arthritis & Rheumatology Research Phoenix Arizona
United States Oregon Health and Science University Portland Oregon
United States Shanahan Rheumatology & Immunotherapy, PLLC Raleigh North Carolina
United States Arthritis Consultants Inc. Saint Louis Missouri
United States Sarasota Arthritis Center Sarasota Florida
United States Arthritis Northwest PLLC Spokane Washington
United States Articularis Healthcare d/b/a/ Low Country Rheumatology, PA Summerville South Carolina
United States Carolina Arthritis Associates Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  Brazil,  Canada,  Czechia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment) A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS =2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 64
Secondary Percentage of Participants Who do Not Experience a Flare A flare is defined as Ankylosing Spondylitis Disease Activity Score (ASDAS =2.1) at 2 consecutive visits, or ASDAS >3.5 at any visit during Period 2.
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with high sensitivity C-reactive protein (CRP) as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 64
Secondary Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS) The mSASSS is a four-point scoring system for lateral radiographs of the lumbar and cervical spine and has been shown to reliably track disease progression over time, where: 0 = normal; 1 = sclerosis, squaring or erosion; 2 = syndesmophyte; 3 = bony bridge.
By the scoring system of mSASSS of the spinal x-rays, a total of 24 sites were scored on the lateral cervical and lumbar spine: the anterior corners of the vertebrae from lower border of C2 to upper border T1 (inclusive), and from lower border of T12 to upper border of S1 (inclusive). Each corner was scored from 0 to 3, resulting in a range from 0 [no change] to 72 [progression].
Baseline, 2 Years
Secondary Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response ASAS20 response is defined as a =20% improvement and an absolute improvement from baseline of =1 units (range 0 to 10) in =3 of 4 domains, and no worsening of =20% and =1 unit (range 0 to 10) in the remaining domain.
The following ASAS domains are used:
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Week 64
Secondary Percentage of Participants Achieving an ASAS40 Response ASAS40 is defined as a =40% improvement and an absolute improvement from baseline of =2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain. The following ASAS domains are used:
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Q5 & Q6 (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Week 64
Secondary Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) =1.1 Units ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness
+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 64
Secondary Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units) ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity. Week 64
Secondary Change From Baseline in the Individual Components of the ASAS Criteria Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function. Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Secondary Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. BASDAI50 represents an improvement of =50% of the BASDAI score from baseline. Week 64
Secondary Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) BASMI is a combined index comprising of the following 5 clinical measurements of spinal mobility in participants with radiographic axial spondyloarthritis (rad-axSpA).
Lateral Spinal Flexion
Tragus-to-wall distance
Lumbar Flexion (modified Schober)
Maximal intermalleolar distance and
Cervical rotation.
The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the participant's limitation of movement due to their AS. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors.
Baseline, Week 64
Secondary Change From Baseline in Chest Expansion in Centimeters Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While participants have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in Occiput to Wall Distance The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) The MASES is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Percentage of Participants With Anterior Uveitis or Uveitis Flares Anterior uveitis is an inflammation of the middle layer of the eye. which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body. Week 64
Secondary Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score The fatigue severity NRS is a participant administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16) The 16-item QIDS-SR16 version is a widely used validated scale designed to assess the severity of depressive symptoms. The participant was asked to rate the severity and frequency of specific symptoms present over the last 7 days. The QIDS-SR16 total scores range from 0 to 27, where higher scores indicate higher severity of symptoms. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in SF-36 Mental Component Summary (MCS) Score The SF-36 is a 36-item participant administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in ASAS Health Index (ASAS HI) The ASAS Health Index (ASAS HI) is a disease specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17 item instrument has scores ranging from 0 (good Health) to 17 (poor Health). Each item consists of 1 question that the participant needs to respond to with either "I agree" (score 1) or "I do not agree (score 0)." A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score The European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0- to 100-mm visual analog scale (VAS). The descriptive system comprises the following 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems, and extreme problems. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA participant population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) The Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Participants report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS mean was determined by ANCOVA with treatment, geographic region, originating study, baseline value and Week 24 value as fixed factors. Baseline, Week 64
Secondary Percentage of Participants With No New Syndesmophyte Formation Percentage of participants with no new syndesmophyte formation was measured using the average of 2 selected readers of 3 readers. Week 56
Secondary Percentage of Participants With Anti-Ixekizumab Antibodies A treatment emergent - antidrug antibody (TE-ADA) positive participant is defined as: a) a participant with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a participant with an increase from the baseline to a level of >= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%. Baseline, Week 64
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