Clinical trial NCT03129100: A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Axial Spondyloarthritis
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
First posted: 2017-04-26
Enrollment: 773
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants Who do Not Experience a Flare (Combined Ixekizumab Treatment)
timeFrame: Week 64
Secondary outcomes:
measure: Percentage of Participants Who do Not Experience a Flare
timeFrame: Week 64
measure: Change From Baseline in Modified Stoke Ankylosing Spondylitis Spinal Score (mSASSS)
timeFrame: Baseline, 2 Years
measure: Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society (ASAS)20 Response
timeFrame: Week 64
measure: Percentage of Participants Achieving an ASAS40 Response
timeFrame: Week 64
measure: Percentage of Participants With Change of Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥1.1 Units
timeFrame: Week 64
measure: Percentage of Participants With Inactive Disease on the ASDAS (<1.3 Units)
timeFrame: Week 64
measure: Change From Baseline in the Individual Components of the ASAS Criteria
timeFrame: Baseline, Week 64
measure: Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
timeFrame: Week 64
measure: Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
timeFrame: Baseline, Week 64
measure: Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
timeFrame: Baseline, Week 64
measure: Change From Baseline in Chest Expansion in Centimeters
timeFrame: Baseline, Week 64
measure: Change From Baseline in Occiput to Wall Distance
timeFrame: Baseline, Week 64
measure: Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
timeFrame: Baseline, Week 64
measure: Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Score
timeFrame: Baseline, Week 64
measure: Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Score of 46 Joints
timeFrame: Baseline, Week 64
measure: Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Score of 44 Joints
timeFrame: Baseline, Week 64
measure: Percentage of Participants With Anterior Uveitis or Uveitis Flares
timeFrame: Week 64
measure: Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
timeFrame: Baseline, Week 64
measure: Change From Baseline on the Quick Inventory of Depressive Symptomatology Self-Report-16 (QIDS-SR16)
timeFrame: Baseline, Week 64
measure: Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
timeFrame: Baseline, Week 64
measure: Change From Baseline in SF-36 Mental Component Summary (MCS) Score
timeFrame: Baseline, Week 64
measure: Change From Baseline in ASAS Health Index (ASAS HI)
timeFrame: Baseline, Week 64
measure: Change From Baseline in the European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) UK Population-based Index Score
timeFrame: Baseline, Week 64
measure: Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
timeFrame: Baseline, Week 64
measure: Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
timeFrame: Baseline, Week 64
measure: Percentage of Participants With No New Syndesmophyte Formation
timeFrame: Week 56
measure: Percentage of Participants With Anti-Ixekizumab Antibodies
timeFrame: Baseline, Week 64
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Arizona Arthritis & Rheumatology Research
state: Arizona
city: Huntington Beach
country: United States
facility: Care Access Research - Huntington Beach
state: California
city: Palm Desert
country: United States
facility: Desert Medical Advances
state: California
city: Colorado Springs
country: United States
facility: Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
state: Colorado
city: Danbury
country: United States
facility: Clinical Research Center of CT/NY
state: Connecticut
city: Aventura
country: United States
facility: Arthritis Rheumatic Disease Specialties
state: Florida
city: Sarasota
country: United States
facility: Sarasota Arthritis Center
state: Florida
city: Marietta
country: United States
facility: Marietta Rheumatology
state: Georgia
city: Idaho Falls
country: United States
facility: Institute of Arthritis Research
state: Idaho
city: Elizabethtown
country: United States
facility: Center for Arthritis & Osteoporosis
state: Kentucky
city: Cumberland
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Hagerstown
country: United States
facility: Klein and Associates MD, PA
state: Maryland
city: Saint Louis
country: United States
facility: Arthritis Consultants Inc.
state: Missouri
city: Kalispell
country: United States
facility: Glacier View Research Institute
state: Montana
city: Lincoln
country: United States
facility: Physician Research Collaboration, LLC
state: Nebraska
city: Raleigh
country: United States
facility: Shanahan Rheumatology & Immunotherapy, PLLC
state: North Carolina
city: Wilmington
country: United States
facility: Carolina Arthritis Associates
state: North Carolina
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Duncansville
country: United States
facility: Altoona Center for Clinical Research
state: Pennsylvania
city: Columbia
country: United States
facility: Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
state: South Carolina
city: Summerville
country: United States
facility: Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
state: South Carolina
city: Houston
country: United States
facility: Univ of Texas Health Science Center - Houston
state: Texas
city: Spokane
country: United States
facility: Arthritis Northwest PLLC
state: Washington
city: Ciudad de Buenos Aires
country: Argentina
facility: Clinica Adventista de Belgrano
state: Buenos Aires
city: Quilmes
country: Argentina
facility: CER Instituto Medico
state: Buenos Aires
city: Rosario
country: Argentina
facility: Centro de Enfermedades del Higado y Aparato Digestivo
state: Santa Fe
city: San Miguel de Tucuman
country: Argentina
facility: Centro Medico Privado de Reumatologia
state: Tucuman
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: Consultorios Reumatologicos Pampa
city: San Miguel de Tucuman
country: Argentina
facility: CIR Centro de Investigacions Reumatologicas
city: Wien
country: Austria
facility: KH der Barmherzigen Schwestern Wien BetriebsGesmbH
city: Juiz de Fora
country: Brazil
facility: CMIP - Centro Mineiro de Pesquisa
state: Minas Gerais
city: Curitiba
country: Brazil
facility: EDUMED - Educação em Saúde Ltda.
state: Paraná
city: Porto Alegre
country: Brazil
facility: LMK Serviços Médicos S/S
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
state: RJ
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RS
city: Sao Paulo
country: Brazil
facility: Cpclin Centro de Pesquisas Clinicas
state: São Paulo
city: Goiás
country: Brazil
facility: CIP - Centro Internacional de Pesquisa
city: Edmonton
country: Canada
facility: University of Alberta Hospital
state: Alberta
city: St. John's
country: Canada
facility: St. Clare's Mercy Hospital
state: Newfoundland and Labrador
city: Trois-Rivieres
country: Canada
facility: Centre de Recherche Musculo-Squelettique
state: Quebec
city: Quebec
country: Canada
facility: Group de recherche en maladies osseuses
city: Brno
country: Czechia
facility: Revmaclinic, s.r.o
city: Ostrava
country: Czechia
facility: Interni a revmatologicka ambulance, Inrea s.r.o.
city: Pardubice
country: Czechia
facility: Arthrohelp s.r.o
city: Praha 2
country: Czechia
facility: Revmatologicky ustav
city: Uherske Hradiste
country: Czechia
facility: MEDICAL PLUS, s.r.o.
city: Helsinki
country: Finland
facility: Helsinki University Hospital, HYKS
city: Helsinki
country: Finland
facility: Terveystalo Kamppi
city: Hyvinkaa
country: Finland
facility: Kiljava Medical Research
city: Chambray-lès-Tours
country: France
facility: Hôpital Trousseau, CHRU de Tours
city: Montpellier Cedex 5
country: France
facility: Centre hospitalier universitaire Lapeyronie
city: Orleans CEDEX 2
country: France
facility: Nouvel Hôpital Orléans La Source
city: Bad Doberan
country: Germany
facility: Rheumazentrum Prof. Neeck
state: Mecklenburg-Vorpommern
city: Herne
country: Germany
facility: Rheumazentrum Ruhrgebiet
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin
city: Hamburg
country: Germany
facility: HRF Hamburger Rheuma Forschungszentrum
city: Budapest
country: Hungary
facility: Revita Reumatologiai Kft.
city: Veszprem
country: Hungary
facility: Vital Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Tel Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Reggio Emilia
country: Italy
facility: Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
city: Sapporo
country: Japan
facility: Hokkaido University Hospital
state: Hokkaido
city: Kita-gun
country: Japan
facility: Kagawa University Hospital
state: Kagawa
city: Nankoku
country: Japan
facility: Kochi Medical School Hospital
state: Kochi
city: Kuwana
country: Japan
facility: Kuwana City Medical Center
state: Mie
city: Sasebo
country: Japan
facility: Sasebo Chuo Hospital
state: Nagasaki
city: Suita-shi
country: Japan
facility: Osaka University Hospital
state: Osaka
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital
state: Tokyo
city: Chuo-Ku
country: Japan
facility: St. Lukes International Hospital
state: Tokyo
city: Okayama
country: Japan
facility: Japanese Red Cross Okayama Hospital
city: Osaka
country: Japan
facility: Osaka City General Hospital
city: Osaka
country: Japan
facility: Osaka City University Hospital
city: Yamagata
country: Japan
facility: Yamagata University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyung Hee University Hospital
state: Korea
city: Seoul
country: Korea, Republic of
facility: Seoul St. Mary's Hospital
state: Korea
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center
state: Seoul
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Hanyang University Medical Center
city: Seoul
country: Korea, Republic of
facility: Konkuk University Hospital
city: Seoul
country: Korea, Republic of
facility: Kyunghee University Hospital at Gangdong
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul Municipal Boramae Hospital
city: Mexicali
country: Mexico
facility: Ctro Inv en Artritis y Osteoporosis SC
state: Baja California
city: Guadalajara
country: Mexico
facility: Unidad de Investigacion en Enfermedades Cronico Degenerative
state: Jalisco
city: Guadalajara
country: Mexico
facility: Clinica en Investigación en Reumatologia y Obesidad S.C.
state: Jalisco
city: Monterrey
country: Mexico
facility: Hospital Universitario de Monterrey
state: Nuevo Leon
city: San Luis Potosi
country: Mexico
facility: Centro de Alta Especialidad Reumatologia Inv del Potosi SC
state: SLP
city: Merida
country: Mexico
facility: Medical Care and Research, S.A. de C.V.
state: Yucatan
city: Chihuahua
country: Mexico
facility: Investigación y Biomedicina de Chihuahua, SC
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum
city: Sneek
country: Netherlands
facility: Antonius Ziekenhuis
city: Bialystok
country: Poland
facility: NZOZ ZDROWIE Osteo-Medic
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im. dr J. Biziela
city: Elblag
country: Poland
facility: Centrum Kliniczno-Badawcze
city: Lodz
country: Poland
facility: Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
city: Nadarzyn
country: Poland
facility: Lecznica MAK-MED, NZOZ
city: Poznan
country: Poland
facility: Prywatna Praktyka Lekarska P. Hrycaj
city: Swidnik
country: Poland
facility: Lubelskie Centrum Diagnostyczne
city: Warszawa
country: Poland
facility: Reumatika Centrum Reumatologii
city: Warszawa
country: Poland
facility: Centrum Medyczne AMED
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC
city: San Juan
country: Puerto Rico
facility: Latin Clinical Trial Center
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research
city: Bucuresti
country: Romania
facility: Spitalul Clinic Sf Maria Bucuresti
city: Constanta
country: Romania
facility: Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
city: Moscow
country: Russian Federation
facility: V.A. Nasonova Research Institute of Rheumatology
city: Moscow
country: Russian Federation
facility: City Clinical Hospital N1
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinincal Cardiology Dispensary
city: Saratov
country: Russian Federation
facility: Saratov State Medical University
city: St. Petersburg
country: Russian Federation
facility: Clinical Rheumatology Hospital # 25
city: Yaroslavl
country: Russian Federation
facility: Clinical Hospital for Emergency Care
city: Sabadell
country: Spain
facility: Centro de Salud Mental Parc Tauli
state: Barcelona
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Sevilla
country: Spain
facility: Hospital Infanta Luisa
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital - Kaohsiung
city: Taichung City
country: Taiwan
facility: Chung Shan Medical University Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Yongkang City
country: Taiwan
facility: Chi-Mei Medical Center
city: Wythenshawe
country: United Kingdom
facility: Wythenshawe Hospital
state: Manchester
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Hospital
state: Norfolk
city: Stoke on Trent
country: United Kingdom
facility: Haywood Hospital
state: Staffordshire
city: Wolverhampton
country: United Kingdom
facility: New Cross Hospital
state: West Midlands
city: Solihull
country: United Kingdom
facility: Solihull Hospital
state: West Midland
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
citation: Braun J, Kiltz U, Deodhar A, Tomita T, Dougados M, Bolce R, Sandoval D, Lin CY, Walsh J. Efficacy and safety of ixekizumab treatment in patients with axial spondyloarthritis: 2-year results from COAST. RMD Open. 2022 Jul;8(2):e002165. doi: 10.1136/rmdopen-2021-002165.