A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
NCT ID: NCT03773978
Last Updated: 2022-10-07
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
220 participants
INTERVENTIONAL
2018-12-17
2022-01-26
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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Baricitinib
Baricitinib was administered QD (once daily) as a 4-mg oral tablet for adolescent participants (12 to \<18 years of age) and children ≥9 years of age; and 2 mg for children \<9 years of age. Participants \<6 years of age received an oral suspension. Participants ≥6 to \<12 years old had the option of receiving an oral suspension. Participants \>12 years old were supplied tablets. The oral suspension dose was administered as 4-mg, 2-mg, 1-mg, and 0.5-mg as needed.
Baricitinib
Administered orally.
Placebo
Placebo matched to baricitinib was administered to participants during the DBW period.
Placebo
Administered orally.
Interventions
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Baricitinib
Administered orally.
Placebo
Administered orally.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 persistent oligoarticular arthritis.
* Participants must not have been previously treated with a Janus kinase (JAK) inhibitor.
2 Years
17 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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Instituto CAICI SRL
Rosario, Santa Fe Province, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Tucumán Province, Argentina
Hospital General de Niños Dr. Pedro de Elizalde
Buenos Aires, , Argentina
The Sydney Children's Hospitals Network
Westmead, New South Wales, Australia
Royal Childrens Hospital Melbourne
Parkville, Victoria, Australia
Perth Children's Hospital
Nedlands, Western Australia, Australia
LKH Bregenz
Bregenz, Vorarlberg, Austria
AKH
Vienna, , Austria
UCL- Saint Luc
Brussels, Brussels Capital, Belgium
UZ Gent-Reuma
Ghent, East Flanders, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, , Belgium
CMIP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, Brazil
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, Brazil
Faculdade de Ciências Médicas - UNICAMP
Campinas, São Paulo, Brazil
Universidade Federal de São Paulo - Escola Paulista de Medicina
São Paulo, , Brazil
Children's hospital of Nanjing
Nanjing, Jiangsu, China
Children's Hospital of Chongqing Medical University
Chongqing, Tianjin City, China
Capitol Institute of Pediatrics Children'S Hospital
Beijing, , China
Beijing Children's hospital, Capital Medical University
Beijing, , China
Children's Hospital of Soochow University
Suzhou, , China
Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze
Prague, , Czechia
Fakultni Nemocnice v Motole
Prague, , Czechia
Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital
Århus N, , Denmark
Paediatric rheumatology Unit
København Ø, , Denmark
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, , France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, , France
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, , France
GH Necker - Enfants Malades
Paris, , France
CHU la Miletrie
Poitiers, , France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, Germany
Asklepios Klinik Sankt Augustin
Saint Augustin, North Rhine-Westphalia, Germany
HELIOS Klinikum Berlin-Buch
Berlin, , Germany
Charité Universitätsmedizin Berlin Campus Buch
Berlin, , Germany
Schön Klinik Hamburg Eilbek
Hamburg, , Germany
Sri Ramachandra MedicaL College & Research Institute
Porur, Chennai, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India
Christian Medical College Vellore
Vellore, Tamil Nadu, India
Rambam Medical Center
Haifa, , Israel
Meir Medical Center
Kfar Saba, , Israel
Schneider Children's Medical Center
Petah Tikva, , Israel
Sheba Medical Center
Ramat Gan, , Israel
ASST Spedali Civili - Università degli Studi
Brescia, , Italy
Ospedale SS. Annunziata
Chieti, , Italy
Azienda Ospedaliero Universitaria Meyer
Florence, , Italy
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
Genova, , Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, , Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, , Italy
Ospedale Infantile Burlo Garofolo
Trieste, , Italy
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
Kanagawa Children's Medical Center
Yokohama, Kanagawa, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, Japan
Miyagi Children's Hospital
Sendai, Miyagi, Japan
Osaka Medical ＆ Pharma Univ Hp
Takatsuki, Osaka, Japan
Saitama Children's Medical Center
Saitama-shi, Saitama, Japan
Tokyo Medical And Dental University Medical Hospital
Bunkyō, Tokyo, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Kagoshima University Hospital
Kagoshima, , Japan
Niigata University Medical & Dental Hospital
Niigata, , Japan
Clinstile, S.A. de C.V.
Cuauhtémoc, Federal District, Mexico
CREA de Guadalajara, S.C.
Guadalajara, Jalisco, Mexico
Hospital Univ. "Dr. José Eleuterio González"
Monterrey, Nuevo León, Mexico
Investigacion y Biomedicina de Chihuahua
Chihuahua City, , Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, , Mexico
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, , Poland
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej
Lodz, , Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, , Poland
V.A. Nasonova Research Institute of Rheumatology
Moscow, , Russia
Morozovsky Children's City Clinical Hospital
Moscow, , Russia
First Moscow State Medical University n.a. Sechenov
Moscow, , Russia
Scientific Center of Children's Health
Moscow, , Russia
Saint-Petersburg State Pediatric Medical University
Saint Petersburg, , Russia
Hospital Sant Joan de Deu
Barcelona, Catalonia, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, , Spain
Hospital Infantil Universitario Niño Jesús
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario La Fe de Valencia
Valencia, , Spain
Istanbul University Cerrahpasa Medical Faculty
Istanbul, , Turkey (Türkiye)
Dokuz Eylul University Hospital
Izmir, , Turkey (Türkiye)
University College Hospital - London
London, Greater London, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
Bloomsbury, London, United Kingdom
Sheffield Children's Hospital
Sheffield, South Yorkshire, United Kingdom
Bristol Royal Hospital for Children
Bristol, , United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, , United Kingdom
Countries
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References
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Krishnan V, Keller SY, Chew C, Sims JT, Chang CY, Dow ER, Benschop RJ, Wang R, Ramanan AV. Serum biomarkers associated with baricitinib response in patients with juvenile idiopathic arthritis: a post-hoc analysis of the phase 3 JUVE-BASIS trial. Lancet Rheumatol. 2025 Sep 4:S2665-9913(25)00153-5. doi: 10.1016/S2665-9913(25)00153-5. Online ahead of print.
Ramanan AV, Quartier P, Okamoto N, Foeldvari I, Spindler A, Fingerhutova S, Anton J, Wang Z, Meszaros G, Araujo J, Liao R, Keller S, Brunner HI, Ruperto N; JUVE-BASIS investigators; Paediatric Rheumatology International Trials Organisation. Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial. Lancet. 2023 Aug 12;402(10401):555-570. doi: 10.1016/S0140-6736(23)00921-2. Epub 2023 Jul 6.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
Other Identifiers
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I4V-MC-JAHV
Identifier Type: OTHER
Identifier Source: secondary_id
2017-004518-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16276
Identifier Type: -
Identifier Source: org_study_id
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