A Long Term Extension Study of Ixekizumab (LY2439821) in Participants With Axial Spondyloarthritis
Study Purpose
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 Criteria
|
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 18 Years and Over |
| Gender | All |
Inclusion Criteria:
- - Have completed the final study visit in Study RHBV (NCT02696785), RHBW (NCT02696798), or RHBX (NCT02757352).
- - 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.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT03129100 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Eli Lilly and Company |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
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) |
| Principal Investigator Affiliation | Eli Lilly and Company |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Recruiting |
| Countries | 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, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Axial Spondyloarthritis |
| Study Website: | View Trial Website |
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Active, not recruiting
Address
Arizona Arthritis & Rheumatology Research
Phoenix, Arizona, 85032
Status
Active, not recruiting
Address
Care Access Research - Huntington Beach
Huntington Beach, California, 92648
Status
Active, not recruiting
Address
Desert Medical Advances
Palm Desert, California, 92260
Status
Active, not recruiting
Address
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado, 80920
Status
Active, not recruiting
Address
Clinical Research Center of CT/NY
Danbury, Connecticut, 06810
Status
Active, not recruiting
Address
Arthritis Rheumatic Disease Specialties
Aventura, Florida, 33180
Status
Active, not recruiting
Address
Sarasota Arthritis Center
Sarasota, Florida, 34239
Status
Active, not recruiting
Address
Marietta Rheumatology
Marietta, Georgia, 30060
Status
Active, not recruiting
Address
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
Status
Active, not recruiting
Address
Center for Arthritis & Osteoporosis
Elizabethtown, Kentucky, 42701
Status
Active, not recruiting
Address
Klein and Associates MD, PA
Cumberland, Maryland, 21502
Status
Active, not recruiting
Address
Klein and Associates MD, PA
Hagerstown, Maryland, 21740
Status
Active, not recruiting
Address
Arthritis Consultants Inc.
Saint Louis, Missouri, 63141
Status
Active, not recruiting
Address
Glacier View Research Institute
Kalispell, Montana, 59901
Status
Active, not recruiting
Address
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Status
Completed
Address
Shanahan Rheumatology & Immunotherapy, PLLC
Raleigh, North Carolina, 27617
Status
Active, not recruiting
Address
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
Status
Active, not recruiting
Address
Oregon Health and Science University
Portland, Oregon, 97239
Status
Active, not recruiting
Address
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
Status
Active, not recruiting
Address
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Columbia, South Carolina, 29204
Status
Active, not recruiting
Address
Articularis Healthcare d/b/a/ Low Country Rheumatology, PA
Summerville, South Carolina, 29486
Status
Active, not recruiting
Address
Univ of Texas Health Science Center - Houston
Houston, Texas, 77030
Status
Active, not recruiting
Address
Arthritis Northwest PLLC
Spokane, Washington, 99204
International Sites
Status
Active, not recruiting
Address
Clinica Adventista de Belgrano
Ciudad de Buenos Aires, Buenos Aires, C1430EGF
Status
Active, not recruiting
Address
CER Instituto Medico
Quilmes, Buenos Aires, B1878DVC
Status
Active, not recruiting
Address
Centro de Enfermedades del Higado y Aparato Digestivo
Rosario, Santa Fe, S2000CFJ
Status
Active, not recruiting
Address
Centro Medico Privado de Reumatologia
San Miguel de Tucuman, Tucuman, T4000AXL
Status
Active, not recruiting
Address
Consultorios Reumatologicos Pampa
Ciudad Autonoma de Buenos Aire, , C1428DZF
Status
Active, not recruiting
Address
CIR Centro de Investigacions Reumatologicas
San Miguel de Tucuman, , 4000
Status
Active, not recruiting
Address
KH der Barmherzigen Schwestern Wien BetriebsGesmbH
Wien, , 1060
Status
Active, not recruiting
Address
CMIP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570
Status
Active, not recruiting
Address
EDUMED - Educação em Saúde Ltda.
Curitiba, Paraná, 80440-080
Status
Active, not recruiting
Address
LMK Serviços Médicos S/S
Porto Alegre, Rio Grande Do Sul, 90540-000
Status
Active, not recruiting
Address
CCBR Brasil Centro de Analises e Pesquisas Clínicas LTDA
Rio de Janeiro, RJ, 22271-100
Status
Active, not recruiting
Address
Hospital de Clinicas de Porto Alegre
Porto Alegre, RS, 90035-903
Status
Active, not recruiting
Address
Cpclin Centro de Pesquisas Clinicas
Sao Paulo, São Paulo, 01228-200
Status
Active, not recruiting
Address
CIP - Centro Internacional de Pesquisa
Goiás, , 74110-120
Status
Active, not recruiting
Address
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7
Status
Active, not recruiting
Address
St. Clare's Mercy Hospital
St. John's, Newfoundland and Labrador, A1C 5B8
Status
Active, not recruiting
Address
Centre de Recherche Musculo-Squelettique
Trois-Rivieres, Quebec, G8Z 1Y2
Status
Active, not recruiting
Address
Group de recherche en maladies osseuses
Quebec, , G1V 3M7
Status
Active, not recruiting
Address
Revmaclinic, s.r.o
Brno, , 611 41
Status
Active, not recruiting
Address
Interni a revmatologicka ambulance, Inrea s.r.o.
Ostrava, , 703 00
Status
Active, not recruiting
Address
Arthrohelp s.r.o
Pardubice, , 530 02
Status
Active, not recruiting
Address
Revmatologicky ustav
Praha 2, , 128 50
Status
Active, not recruiting
Address
MEDICAL PLUS, s.r.o.
Uherske Hradiste, , 686 01
Status
Active, not recruiting
Address
Helsinki University Hospital, HYKS
Helsinki, , 00029
Status
Active, not recruiting
Address
Terveystalo Kamppi
Helsinki, , 00100
Status
Active, not recruiting
Address
Kiljava Medical Research
Hyvinkaa, , 05800
Status
Active, not recruiting
Address
Hôpital Trousseau, CHRU de Tours
Chambray-lès-Tours, , 37170
Status
Active, not recruiting
Address
Centre hospitalier universitaire Lapeyronie
Montpellier Cedex 5, , 34295
Status
Active, not recruiting
Address
Nouvel Hôpital Orléans La Source
Orleans CEDEX 2, , 45067
Status
Active, not recruiting
Address
Rheumazentrum Prof. Neeck
Bad Doberan, Mecklenburg-Vorpommern, 18209
Status
Active, not recruiting
Address
Rheumazentrum Ruhrgebiet
Herne, Nordrhein-Westfalen, 44649
Status
Recruiting
Address
Charité Universitätsmedizin Berlin
Berlin, , 12203
Status
Active, not recruiting
Address
HRF Hamburger Rheuma Forschungszentrum
Hamburg, , 20095
Status
Active, not recruiting
Address
Revita Reumatologiai Kft.
Budapest, , 1027
Status
Active, not recruiting
Address
Vital Medical Center
Veszprem, , 8200
Status
Active, not recruiting
Address
Barzilai Medical Center
Ashkelon, , 7830604
Status
Active, not recruiting
Address
Rambam Medical Center
Haifa, , 3109601
Status
Active, not recruiting
Address
Rabin Medical Center
Petach Tikva, , 4941492
Status
Active, not recruiting
Address
Tel Aviv Sourasky Medical Center
Tel Aviv, , 6423906
Status
Active, not recruiting
Address
Arcispedale Santa Maria Nuova Azienda Ospedaliera di Reggio Emilia
Reggio Emilia, , 42123
Status
Active, not recruiting
Address
Hokkaido University Hospital
Sapporo, Hokkaido, 060-8648
Status
Active, not recruiting
Address
Kagawa University Hospital
Kita-gun, Kagawa, 761-0793
Status
Active, not recruiting
Address
Kochi Medical School Hospital
Nankoku, Kochi, 783-8505
Status
Active, not recruiting
Address
Kuwana City Medical Center
Kuwana, Mie, 511-0061
Status
Active, not recruiting
Address
Sasebo Chuo Hospital
Sasebo, Nagasaki, 857-1195
Status
Active, not recruiting
Address
Osaka University Hospital
Suita-shi, Osaka, 565 0871
Status
Active, not recruiting
Address
Juntendo University Hospital
Bunkyo-ku, Tokyo, 113-8431
Status
Active, not recruiting
Address
St. Lukes International Hospital
Chuo-Ku, Tokyo, 104 8560
Status
Active, not recruiting
Address
Japanese Red Cross Okayama Hospital
Okayama, , 700-8607
Status
Active, not recruiting
Address
Osaka City General Hospital
Osaka, , 534-0021
Status
Active, not recruiting
Address
Osaka City University Hospital
Osaka, , 545-8586
Status
Active, not recruiting
Address
Yamagata University Hospital
Yamagata, , 990-9585
Status
Active, not recruiting
Address
Kyung Hee University Hospital
Seoul, Korea, 02447
Status
Active, not recruiting
Address
Seoul St. Mary's Hospital
Seoul, Korea, 06591
Status
Active, not recruiting
Address
Asan Medical Center
Songpa-gu, Seoul, 05505
Status
Active, not recruiting
Address
Chungnam National University Hospital
Daejeon, , 35015
Status
Active, not recruiting
Address
Seoul National University Hospital
Seoul, , 03080
Status
Active, not recruiting
Address
Hanyang University Medical Center
Seoul, , 04763
Status
Active, not recruiting
Address
Konkuk University Hospital
Seoul, , 05030
Status
Active, not recruiting
Address
Kyunghee University Hospital at Gangdong
Seoul, , 05278
Status
Active, not recruiting
Address
Gangnam Severance Hospital
Seoul, , 06273
Status
Active, not recruiting
Address
Seoul Municipal Boramae Hospital
Seoul, , 07061
Status
Active, not recruiting
Address
Ctro Inv en Artritis y Osteoporosis SC
Mexicali, Baja California, 21200
Status
Active, not recruiting
Address
Unidad de Investigacion en Enfermedades Cronico Degenerative
Guadalajara, Jalisco, 44620
Status
Active, not recruiting
Address
Clinica en Investigación en Reumatologia y Obesidad S.C.
Guadalajara, Jalisco, 44650
Status
Active, not recruiting
Address
Hospital Universitario de Monterrey
Monterrey, Nuevo Leon, 64460
Status
Active, not recruiting
Address
Centro de Alta Especialidad Reumatologia Inv del Potosi SC
San Luis Potosi, SLP, 78213
Status
Active, not recruiting
Address
Medical Care and Research, S.A. de C.V.
Merida, Yucatan, 97070
Status
Active, not recruiting
Address
Investigación y Biomedicina de Chihuahua, SC
Chihuahua, , 31000
Status
Active, not recruiting
Address
Academisch Medisch Centrum
Amsterdam, , 1105 AZ
Status
Active, not recruiting
Address
Antonius Ziekenhuis
Sneek, , 8601 ZK
Status
Active, not recruiting
Address
NZOZ ZDROWIE Osteo-Medic
Bialystok, , 15-351
Status
Active, not recruiting
Address
Szpital Uniwersytecki nr 2 im. dr J. Biziela
Bydgoszcz, , 85-168
Status
Active, not recruiting
Address
Centrum Kliniczno-Badawcze
Elblag, , 82-300
Status
Active, not recruiting
Address
Centrum Leczenia Osteoporozy Klinika Zdrowej Kosci
Lodz, , 90-558
Status
Active, not recruiting
Address
Lecznica MAK-MED, NZOZ
Nadarzyn, , 05-830
Status
Active, not recruiting
Address
Prywatna Praktyka Lekarska P. Hrycaj
Poznan, , 61-397
Status
Active, not recruiting
Address
Lubelskie Centrum Diagnostyczne
Swidnik, , 21-040
Status
Active, not recruiting
Address
Reumatika Centrum Reumatologii
Warszawa, , 02-691
Status
Active, not recruiting
Address
Centrum Medyczne AMED
Warszawa, , 03-291
Status
Active, not recruiting
Address
GCM Medical Group PSC
San Juan, , 00909
Status
Active, not recruiting
Address
Latin Clinical Trial Center
San Juan, , 00909
Status
Active, not recruiting
Address
Mindful Medical Research
San Juan, , 00918
Status
Active, not recruiting
Address
Spitalul Clinic Sf Maria Bucuresti
Bucuresti, , 011172
Status
Active, not recruiting
Address
Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanta, , 900591
Status
Active, not recruiting
Address
V.A. Nasonova Research Institute of Rheumatology
Moscow, , 115522
Status
Active, not recruiting
Address
City Clinical Hospital N1
Moscow, , 119049
Status
Active, not recruiting
Address
Ryazan Regional Clinincal Cardiology Dispensary
Ryazan, , 390026
Status
Active, not recruiting
Address
Saratov State Medical University
Saratov, , 410026
Status
Active, not recruiting
Address
Clinical Rheumatology Hospital # 25
St. Petersburg, , 190068
Status
Active, not recruiting
Address
Clinical Hospital for Emergency Care
Yaroslavl, , 150003
Status
Active, not recruiting
Address
Centro de Salud Mental Parc Tauli
Sabadell, Barcelona, 08208
Status
Active, not recruiting
Address
Hospital General Universitario Gregorio Marañon
Madrid, , 28007
Status
Active, not recruiting
Address
Hospital Infanta Luisa
Sevilla, , 41010
Status
Active, not recruiting
Address
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung, , 83301
Status
Active, not recruiting
Address
Chung Shan Medical University Hospital
Taichung City, , 40201
Status
Active, not recruiting
Address
China Medical University Hospital
Taichung, , 40447
Status
Active, not recruiting
Address
National Taiwan University Hospital
Taipei, , 10002
Status
Active, not recruiting
Address
Chi-Mei Medical Center
Yongkang City, , 71004
Status
Active, not recruiting
Address
Wythenshawe Hospital
Wythenshawe, Manchester, M23 9LT
Status
Active, not recruiting
Address
Norfolk and Norwich Hospital
Norwich, Norfolk, NR4 7UY
Status
Active, not recruiting
Address
Haywood Hospital
Stoke on Trent, Staffordshire, ST6 7AG
Status
Active, not recruiting
Address
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
Status
Active, not recruiting
Address
Solihull Hospital
Solihull, West Midland, B91 2JL
