A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Study Purpose
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with JIA from 2 years to less than 18 years old.
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 | 2 Years - 17 Years |
Gender | All |
Inclusion Criteria:
- - Participants must have had a diagnosis of active JIA (polyarticular, extended oligoarticular, or enthesitis-related juvenile idiopathic arthritis [ERA] including JPsA).
- - Participants must have had an inadequate response to at least one conventional or biologic disease-modifying antirheumatic drug (DMARD).
Exclusion Criteria:
- - Participants must not have systemic JIA, with or without active systemic features.
- - Participants must not have persistent oligoarticular arthritis.
- - Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.
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. |
NCT03773978 |
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, Australia, Austria, Belgium, Brazil, China, Czechia, Denmark, France, Germany, India, Israel, Italy, Japan, Mexico, Poland, Russian Federation, Spain, Turkey, United Kingdom |
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Juvenile Idiopathic Arthritis |
Study Website: | View Trial Website |
Arms
Experimental: Baricitinib Open-Label
Baricitinib given orally.
Experimental: Baricitinib Double Blind
Baricitinib given orally.
Placebo Comparator: Placebo Double Blind
Placebo given orally.
Interventions
Drug: - Baricitinib
Administered orally.
Drug: - Placebo
Administered orally.
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.
International Sites
Status
Recruiting
Address
Instituto CAICI SRL
Rosario, Santa Fe, 2000
Status
Recruiting
Address
Centro Medico Privado de Reumatologia
SAN M. DE Tucuman, Tucumán, T4000AXL
Status
Recruiting
Address
Hospital General de Niños Dr. Pedro de Elizalde
Buenos Aires, , C1270AAN
Status
Recruiting
Address
The Sydney Children's Hospitals Network
Westmead, New South Wales, 2145
Status
Recruiting
Address
Royal Childrens Hospital Melbourne
Parkville, Victoria, 3050
Status
Recruiting
Address
Perth Children's Hospital
Nedlands, Western Australia, 6009
Status
Recruiting
Address
LKH Bregenz
Bregenz, Vorarlberg, 6900
Status
Recruiting
Address
UCL- Saint Luc
Brussels, Brussels-Capital, 1200
Status
Recruiting
Address
UZ Gent-Reuma
Gent, East Flanders, 9000
Status
Recruiting
Address
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , 3000
Status
Recruiting
Address
CMIP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570
Status
Recruiting
Address
Faculdade de Medicina de Botucatu
Botucatu, Sao Paulo, 18618-970
Status
Recruiting
Address
Faculdade de Ciências Médicas - UNICAMP
Campinas, Sao Paulo, 13083-887
Status
Recruiting
Address
Universidade Federal de São Paulo - Escola Paulista de Medicina
São Paulo, , 04038-001
Status
Recruiting
Address
Children's hospital of Nanjing
Nanjing, Jiangsu, 210008
Status
Active, not recruiting
Address
Children's Hospital of Chongqing Medical University
Chongqing, Tianjin City, 200041
Status
Recruiting
Address
Capitol Institute of Pediatrics Children'S Hospital
Beijing, , 100020
Status
Recruiting
Address
Beijing Children's hospital, Capital Medical University
Beijing, , 100045
Status
Recruiting
Address
Children's Hospital of Soochow University
Suzhou, , 215025
Status
Recruiting
Address
Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze
Prague, , 121 08
Status
Recruiting
Address
Fakultni Nemocnice v Motole
Praha 5, , 15006
Status
Recruiting
Address
Paediatric rheumatology Unit
København Ø, , 2100
Status
Recruiting
Address
Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital
Århus N, , 8200
Status
Recruiting
Address
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, , 69500
Status
Recruiting
Address
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin Bicetre, , 94270
Status
Recruiting
Address
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , 30029
Status
Recruiting
Address
GH Necker - Enfants Malades
Paris Cedex 15, , 75743
Status
Recruiting
Address
CHU la Miletrie
Poitiers, , 86000
Status
Recruiting
Address
Universitätsklinikum Heidelberg
Heidelberg, Baden-Württemberg, 69120
Status
Recruiting
Address
Universitätsklinikum Tübingen
Tübingen, Baden-Württemberg, 72076
Status
Recruiting
Address
Asklepios Klinik Sankt Augustin
Saint Augustin, Nordrhein-Westfalen, 53757
Status
Recruiting
Address
HELIOS Klinikum Berlin-Buch
Berlin, , 13125
Status
Recruiting
Address
Charité Campus Virchow-Klinikum
Berlin, , 13353
Status
Recruiting
Address
Schön Klinik Hamburg Eilbek
Hamburg, , 22081
Status
Recruiting
Address
Sri Ramachandra MedicaL College & Research Institute
Porur, Chennai, 600116
Status
Recruiting
Address
Sir Ganga Ram Hospital
New Delhi, Delhi, 110060
Status
Recruiting
Address
Christian Medical College Vellore
Vellore, Tamil Nadu, 632 004
Status
Recruiting
Address
Rambam Medical Center
Haifa, , 3109601
Status
Recruiting
Address
Meir Medical Center
Kfar Saba, , 4428164
Status
Recruiting
Address
Schneider Children's Medical Center
Petah Tiqva, , 4920235
Status
Recruiting
Address
Sheba Medical Center
Ramat Gan, , 5265601
Status
Recruiting
Address
ASST Spedali Civili - Università degli Studi
Brescia, , 25123
Status
Recruiting
Address
Ospedale SS. Annunziata
Chieti, , 66100
Status
Recruiting
Address
Azienda Ospedaliero Universitaria Meyer
Firenze, , 50139
Status
Recruiting
Address
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
Genova, , 16147
Status
Completed
Address
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milano, , 20122
Status
Recruiting
Address
Azienda Ospedaliera Universitaria Federico II
Napoli, , 80131
Status
Recruiting
Address
Ospedale Infantile Burlo Garofolo
Trieste, , 34137
Status
Recruiting
Address
Kanazawa University Hospital
Kanazawa, Ishikawa, 920 8641
Status
Recruiting
Address
Kanagawa Children's Medical Center
Yokohama, Kanagawa, 232-8555
Status
Recruiting
Address
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004
Status
Recruiting
Address
Miyagi Children's Hospital
Sendai, Miyagi, 989-3126
Status
Recruiting
Address
Osaka Medical College Hospital
Takatsuki, Osaka, 569-8686
Status
Recruiting
Address
Saitama Children's Medical Center
Saitama-shi, Saitama, 330 8777
Status
Recruiting
Address
Tokyo Medical And Dental University Medical Hospital
Bunkyō, Tokyo, 113-8519
Status
Recruiting
Address
St. Lukes International Hospital
Chuo-Ku, Tokyo, 104 8560
Status
Recruiting
Address
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666
Status
Recruiting
Address
Kagoshima University Hospital
Kagoshima, , 890-8520
Status
Recruiting
Address
Niigata University Medical & Dental Hospital
Niigata, , 951-8520
Status
Recruiting
Address
Clinstile, S.A. de C.V.
Cuauhtemoc, Federal District, 06700
Status
Recruiting
Address
CREA de Guadalajara, S.C.
Guadalajara, Jalisco, 44620
Status
Recruiting
Address
Hospital Univ. "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460
Status
Recruiting
Address
Investigacion y Biomedicina de Chihuahua
Chihuahua, , 31000
Status
Recruiting
Address
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, , 34000
Status
Recruiting
Address
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, , 31-503
Status
Recruiting
Address
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej
Lodz, , 91-738
Status
Recruiting
Address
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warszawa, , 02-637
Status
Recruiting
Address
V.A. Nasonova Research Institute of Rheumatology
Moscow, , 115522
Status
Recruiting
Address
Morozovsky Children's City Clinical Hospital
Moscow, , 119049
Status
Recruiting
Address
First Moscow State Medical University n.a. Sechenov
Moscow, , 119991
Status
Recruiting
Address
Scientific Center of Children's Health
Moscow, , 119991
Status
Recruiting
Address
Saint-Petersburg State Pediatric Medical University
Saint Petersburg, , 194100
Status
Recruiting
Address
Hospital Sant Joan de Deu
Barcelona, Cataluna, 08950
Status
Recruiting
Address
Complexo Hospitalario Universitario A Coruña, CHUAC
La Coruña, , 15006
Status
Recruiting
Address
Hospital Infantil Universitario Niño Jesús
Madrid, , 28009
Status
Recruiting
Address
Hospital Universitario Ramón y Cajal
Madrid, , 28034
Status
Recruiting
Address
Hospital Universitario La Paz
Madrid, , 28046
Status
Recruiting
Address
Hospital Universitario La Fe de Valencia
Valencia, , 46026
Status
Recruiting
Address
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , 34098
Status
Recruiting
Address
Dokuz Eylul University Hospital
Izmir, , 35340
Status
Recruiting
Address
University College Hospital - London
London, Greater London, W1T 7HA
Status
Recruiting
Address
Great Ormond Street Hospital For Children NHS Foundation Trust
Bloomsbury, London, WC1N 3JH
Status
Recruiting
Address
Sheffield Children's Hospital
Sheffield, South Yorkshire, S10 2TH
Status
Recruiting
Address
Bristol Royal Hospital for Children
Bristol, , BS2 8BJ
Status
Recruiting
Address
Alder Hey Children's NHS Foundation Trust
Liverpool, , L14 5AB