A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
NCT ID: NCT03129100
Last Updated: 2022-06-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
773 participants
INTERVENTIONAL
2017-05-09
2021-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Ixekizumab (IXE) 80Q4W
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every four weeks (Q4W).
Ixekizumab
Administered SC
Ixekizumab (IXE) 80Q2W
Participants received 80 milligram (mg) of Ixekizumab subcutaneously (SC) every two weeks (Q2W).
Ixekizumab
Administered SC
Placebo
Participants received subcutaneous dose of placebo.
Placebo
Administered SC
Interventions
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Ixekizumab
Administered SC
Placebo
Administered SC
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
(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 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.
18 Years
ALL
No
Sponsors
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Eli Lilly and Company
INDUSTRY
Responsible Party
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Principal Investigators
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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
Eli Lilly and Company
Locations
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Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, United States
Care Access Research - Huntington Beach
Huntington Beach, California, United States
Desert Medical Advances
Palm Desert, California, United States
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado, United States
Clinical Research Center of CT/NY
Danbury, Connecticut, United States
Arthritis Rheumatic Disease Specialties
Aventura, Florida, United States
Sarasota Arthritis Center
Sarasota, Florida, United States
Marietta Rheumatology
Marietta, Georgia, United States
Institute of Arthritis Research
Idaho Falls, Idaho, United States
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, United States
Klein and Associates MD, PA
Cumberland, Maryland, United States
Klein and Associates MD, PA
Hagerstown, Maryland, United States
Arthritis Consultants Inc.
St Louis, Missouri, United States
Glacier View Research Institute
Kalispell, Montana, United States
Physician Research Collaboration, LLC
Lincoln, Nebraska, United States
Shanahan Rheumatology & Immunotherapy, PLLC
Raleigh, North Carolina, United States
Carolina Arthritis Associates
Wilmington, North Carolina, United States
Oregon Health and Science University
Portland, Oregon, United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, United States
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Columbia, South Carolina, United States
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville, South Carolina, United States
Univ of Texas Health Science Center - Houston
Houston, Texas, United States
Arthritis Northwest PLLC
Spokane, Washington, United States
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 Province, Argentina
Centro Medico Privado de Reumatologia
San Miguel de Tucumán, Tucumán Province, Argentina
Consultorios Reumatologicos Pampa
Ciudad Autonoma de Buenos Aire, , Argentina
CIR Centro de Investigacions Reumatologicas
San Miguel de Tucumán, , Argentina
KH der Barmherzigen Schwestern Wien BetriebsGesmbH
Vienna, , Austria
CMIP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, Brazil
EDUMED - Educação em Saúde Ltda.
Curitiba, Paraná, Brazil
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande do Sul, Brazil
Cpclin Centro de Pesquisas Clinicas
São Paulo, São Paulo, Brazil
CIP - Centro Internacional de Pesquisa
Goiás, , Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, Canada
Centre de Recherche Musculo-Squelettique
Trois-Rivières, Quebec, Canada
Group de recherche en maladies osseuses
Québec, , Canada
Revmaclinic, s.r.o
Brno, , Czechia
Interni a revmatologicka ambulance, Inrea s.r.o.
Ostrava, , Czechia
Arthrohelp s.r.o
Pardubice, , Czechia
Revmatologicky ustav
Prague, , Czechia
MEDICAL PLUS, s.r.o.
Uherské Hradiště, , Czechia
Helsinki University Hospital, HYKS
Helsinki, , Finland
Terveystalo Kamppi
Helsinki, , Finland
Kiljava Medical Research
Hyvinkää, , Finland
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, , France
Centre hospitalier universitaire Lapeyronie
Montpellier, , France
Nouvel Hôpital Orléans La Source
Orléans, , France
Rheumazentrum Prof. Neeck
Bad Doberan, Mecklenburg-Vorpommern, Germany
Rheumazentrum Ruhrgebiet
Herne, North Rhine-Westphalia, Germany
Charité Universitätsmedizin Berlin
Berlin, , Germany
HRF Hamburger Rheuma Forschungszentrum
Hamburg, , Germany
Revita Reumatologiai Kft.
Budapest, , Hungary
Vital Medical Center
Veszprém, , Hungary
Barzilai Medical Center
Ashkelon, , Israel
Rambam Medical Center
Haifa, , Israel
Rabin Medical Center
Petah Tikva, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, , Italy
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kagawa University Hospital
Kita-gun, Kagawa-ken, Japan
Kochi Medical School Hospital
Nankoku, Kochi, Japan
Kuwana City Medical Center
Kuwana, Mie-ken, Japan
Sasebo Chuo Hospital
Sasebo, Nagasaki, Japan
Osaka University Hospital
Suita-shi, Osaka, Japan
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, Japan
Japanese Red Cross Okayama Hospital
Okayama, , Japan
Osaka City General Hospital
Osaka, , Japan
Osaka City University Hospital
Osaka, , Japan
Yamagata University Hospital
Yamagata, , Japan
Ctro Inv en Artritis y Osteoporosis SC
Mexicali, Estado de Baja California, Mexico
Unidad de Investigacion en Enfermedades Cronico Degenerative
Guadalajara, Jalisco, Mexico
Clinica en Investigación en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, Mexico
Hospital Universitario de Monterrey
Monterrey, Nuevo León, Mexico
Centro de Alta Especialidad Reumatologia Inv del Potosi SC
San Luis Potosí City, San Luis Potosí, Mexico
Medical Care and Research, S.A. de C.V.
Mérida, Yucatán, Mexico
Investigación y Biomedicina de Chihuahua, SC
Chihuahua City, , Mexico
Academisch Medisch Centrum
Amsterdam, , Netherlands
Antonius Ziekenhuis
Sneek, , Netherlands
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
Świdnik, , Poland
Reumatika Centrum Reumatologii
Warsaw, , Poland
Centrum Medyczne AMED
Warsaw, , Poland
GCM Medical Group PSC
San Juan, PR, Puerto Rico
Latin Clinical Trial Center
San Juan, PR, Puerto Rico
Mindful Medical Research
San Juan, PR, Puerto Rico
Spitalul Clinic Sf Maria Bucuresti
Bucharest, , Romania
Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanța, , Romania
V.A. Nasonova Research Institute of Rheumatology
Moscow, , Russia
City Clinical Hospital N1
Moscow, , Russia
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, , Russia
Clinical Rheumatology Hospital # 25
Saint Petersburg, , Russia
Saratov State Medical University
Saratov, , Russia
Clinical Hospital for Emergency Care
Yaroslavl, , Russia
Kyung Hee University Hospital
Seoul, Korea, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, South Korea
Asan Medical Center
Songpa-gu, Seoul, South Korea
Chungnam National University Hospital
Daejeon, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Hanyang University Medical Center
Seoul, , South Korea
Konkuk University Hospital
Seoul, , South Korea
Kyunghee University Hospital at Gangdong
Seoul, , South Korea
Gangnam Severance Hospital
Seoul, , South Korea
Seoul Municipal Boramae Hospital
Seoul, , South Korea
Centro de Salud Mental Parc Tauli
Sabadell, Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Infanta Luisa
Seville, , Spain
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City, , Taiwan
Chung Shan Medical University Hospital
Taichung, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chi-Mei Medical Center
Yongkang District, , Taiwan
Wythenshawe Hospital
Wythenshawe, Manchester, United Kingdom
Norfolk and Norwich Hospital
Norwich, Norfolk, United Kingdom
Haywood Hospital
Stoke-on-Trent, Staffordshire, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, United Kingdom
Solihull Hospital
Solihull, West Midland, United Kingdom
Countries
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References
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Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis (COAST-Y)
Other Identifiers
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I1F-MC-RHBY
Identifier Type: OTHER
Identifier Source: secondary_id
2016-002634-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16181
Identifier Type: -
Identifier Source: org_study_id
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