A Study of Baricitinib in Participants From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
JUVE-BASIS
A Randomized, Double-Blind, Placebo-Controlled, Withdrawal, Safety and Efficacy Study of Oral Baricitinib in Patients From 2 Years to Less Than 18 Years Old With Juvenile Idiopathic Arthritis (JIA)
3 other identifiers
interventional
220
19 countries
84
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2018
Typical duration for phase_3
84 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2018
CompletedFirst Posted
Study publicly available on registry
December 12, 2018
CompletedStudy Start
First participant enrolled
December 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 26, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 26, 2022
CompletedResults Posted
Study results publicly available
October 7, 2022
CompletedOctober 7, 2022
September 1, 2022
3.1 years
December 11, 2018
July 22, 2022
September 8, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Disease Flare
A disease flare is defined as a worsening of 30% or more in at least three of the six core Paediatric American College of Rheumatology (PedACR) criteria for juvenile rheumatoid arthritis (JIA) and an improvement of 30% or more in no more than one of the criteria. The six PedACR criteria are: 1) the number of active joints, 2) the number of joints with limited range of motion, 3) physician's global assessment of disease activity, 4) parent's global assessment of the participant's overall well-being, 5) physical function as measured by the Childhood Health Assessment Questionnaire (CHAQ) and 6) acute-phase reactant (high-sensitivity C-reactive protein \[hsCRP\] and erythrocyte sedimentation rate \[ESR\]), the ESR measure is only used as an acute phase reactant in the core criteria.
Week 12 to Week 44
Secondary Outcomes (18)
Percentage of Participants Achieving PedACR30 Responder Index
Week 16, 20, 24, 28, 32, 36, 40 and 44
Percentage of Participants Achieving PedACR50 Responder Index
Week 16, 20, 24, 28, 32, 36, 40 and 44
Percentage of Participants Achieving PedACR70 Responder Index
Week 16, 20, 24, 28, 32, 36, 40 and 44
Percentage of Participants Achieving PedACR90 Responder Index
Week 16, 20, 24, 28, 32, 36, 40 and 44
Percentage of Participants Achieving PedACR100 Responder Index
Week 16, 20, 24, 28, 32, 36, 40 and 44
- +13 more secondary outcomes
Study Arms (2)
Baricitinib
EXPERIMENTALBaricitinib 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.
Placebo
PLACEBO COMPARATORPlacebo matched to baricitinib was administered to participants during the DBW period.
Interventions
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (86)
Instituto CAICI SRL
Rosario, Santa Fe Province, 2000, Argentina
Centro Medico Privado de Reumatologia
SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Hospital General de Niños Dr. Pedro de Elizalde
Buenos Aires, C1270AAN, Argentina
The Sydney Children's Hospitals Network
Westmead, New South Wales, 2145, Australia
Royal Childrens Hospital Melbourne
Parkville, Victoria, 3050, Australia
Perth Children's Hospital
Nedlands, Western Australia, 6009, Australia
LKH Bregenz
Bregenz, Vorarlberg, 6900, Austria
AKH
Vienna, 1090, Austria
UCL- Saint Luc
Brussels, Brussels Capital, 1200, Belgium
UZ Gent-Reuma
Ghent, East Flanders, 9000, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
CMIP - Centro Mineiro de Pesquisa
Juiz de Fora, Minas Gerais, 36010-570, Brazil
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, 18618-970, Brazil
Faculdade de Ciências Médicas - UNICAMP
Campinas, São Paulo, 13083-887, Brazil
Universidade Federal de São Paulo - Escola Paulista de Medicina
São Paulo, 04038-001, Brazil
Children's hospital of Nanjing
Nanjing, Jiangsu, 210008, China
Children's Hospital of Chongqing Medical University
Chongqing, Tianjin City, 200041, China
Capitol Institute of Pediatrics Children'S Hospital
Beijing, 100020, China
Beijing Children's hospital, Capital Medical University
Beijing, 100045, China
Children's Hospital of Soochow University
Suzhou, 215025, China
Centrum detske revmatologie VFN, Klinika detskeho a dorostoveho lekarstvi 1.LFUK a VFN v Praze
Prague, 121 08, Czechia
Fakultni Nemocnice v Motole
Prague, 15006, Czechia
Center for Børnereumatologi. Børn og Unge, Århus Universitetshospital
Århus N, 8200, Denmark
Paediatric rheumatology Unit
København Ø, 2100, Denmark
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, 69500, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, 94270, France
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, 30029, France
GH Necker - Enfants Malades
Paris, 75743, France
CHU la Miletrie
Poitiers, 86000, France
Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, 69120, Germany
Universitätsklinikum Tübingen
Tübingen, Baden-Wurttemberg, 72076, Germany
Asklepios Klinik Sankt Augustin
Saint Augustin, North Rhine-Westphalia, 53757, Germany
HELIOS Klinikum Berlin-Buch
Berlin, 13125, Germany
Charité Universitätsmedizin Berlin Campus Buch
Berlin, 13353, Germany
Schön Klinik Hamburg Eilbek
Hamburg, 22081, Germany
Sri Ramachandra MedicaL College & Research Institute
Porur, Chennai, 600116, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Christian Medical College Vellore
Vellore, Tamil Nadu, 632 004, India
Rambam Medical Center
Haifa, 3109601, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Schneider Children's Medical Center
Petah Tikva, 4920235, Israel
Sheba Medical Center
Ramat Gan, 5265601, Israel
ASST Spedali Civili - Università degli Studi
Brescia, 25123, Italy
Ospedale SS. Annunziata
Chieti, 66100, Italy
Azienda Ospedaliero Universitaria Meyer
Florence, 50139, Italy
Ospedale Pediatrico Gaslini - Istituto Giannina Gaslini
Genova, 16147, Italy
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Ospedale Infantile Burlo Garofolo
Trieste, 34137, Italy
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920 8641, Japan
Kanagawa Children's Medical Center
Yokohama, Kanagawa, 232-8555, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
Miyagi Children's Hospital
Sendai, Miyagi, 989-3126, Japan
Osaka Medical ＆ Pharma Univ Hp
Takatsuki, Osaka, 569-8686, Japan
Saitama Children's Medical Center
Saitama-shi, Saitama, 330 8777, Japan
Tokyo Medical And Dental University Medical Hospital
Bunkyō, Tokyo, 113-8519, Japan
St. Lukes International Hospital
Chuo-Ku, Tokyo, 104 8560, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, Tokyo, 162-8666, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Clinstile, S.A. de C.V.
Cuauhtémoc, Federal District, 06700, Mexico
CREA de Guadalajara, S.C.
Guadalajara, Jalisco, 44620, Mexico
Hospital Univ. "Dr. José Eleuterio González"
Monterrey, Nuevo León, 64460, Mexico
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C
Durango, 34000, Mexico
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, 31-503, Poland
CSK, Uniwersyteckie Centrum Pediatrii im.M.Konopnickiej,Klinika Kardiologii i Reumatologii Dzieciecej
Lodz, 91-738, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637, Poland
V.A. Nasonova Research Institute of Rheumatology
Moscow, 115522, Russia
Morozovsky Children's City Clinical Hospital
Moscow, 119049, Russia
First Moscow State Medical University n.a. Sechenov
Moscow, 119991, Russia
Scientific Center of Children's Health
Moscow, 119991, Russia
Saint-Petersburg State Pediatric Medical University
Saint Petersburg, 194100, Russia
Hospital Sant Joan de Deu
Barcelona, Catalonia, 08950, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, 15006, Spain
Hospital Infantil Universitario Niño Jesús
Madrid, 28009, Spain
Hospital Universitario Ramón y Cajal
Madrid, 28034, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario La Fe de Valencia
Valencia, 46026, Spain
Istanbul University Cerrahpasa Medical Faculty
Istanbul, 34098, Turkey (Türkiye)
Dokuz Eylul University Hospital
Izmir, 35340, Turkey (Türkiye)
University College Hospital - London
London, Greater London, W1T 7HA, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
Bloomsbury, London, WC1N 3JH, United Kingdom
Sheffield Children's Hospital
Sheffield, South Yorkshire, S10 2TH, United Kingdom
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
Alder Hey Children's NHS Foundation Trust
Liverpool, L14 5AB, United Kingdom
Related Publications (2)
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 Nov;7(11):e799-e807. doi: 10.1016/S2665-9913(25)00153-5. Epub 2025 Sep 4.
PMID: 40915298DERIVEDRamanan 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.
PMID: 37423231DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- STUDY DIRECTOR
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)
Eli Lilly and Company
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 12, 2018
Study Start
December 17, 2018
Primary Completion
January 26, 2022
Study Completion
January 26, 2022
Last Updated
October 7, 2022
Results First Posted
October 7, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.