A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis

Axial Spondyloarthritis Clinical Trial

Official title:

A Multicenter, Long-Term Extension Study of 104 Weeks, Including a Double-Blind, Placebo-Controlled 40-Week Randomized Withdrawal-Retreatment Period, to Evaluate the Maintenance of Treatment Effect of Ixekizumab (LY2439821) in Patients With Axial Spondyloarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03129100
• Other study ID #: 16181
• Secondary ID: I1F-MC-RHBY2016-
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Axial Spondyloarthritis
• Spondylarthritis

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

External Links

•   A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis (COAST-Y)