A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
JUVE-X
A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to <18 Years of Age With Juvenile Idiopathic Arthritis (JIA)
3 other identifiers
interventional
190
19 countries
81
Brief Summary
The reason for this study is to see if the study drug baricitinib is safe and effective in the treatment of JIA in participants ages 1 to 17. This study is for participants that have been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.
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 Apr 2019
Longer than P75 for phase_3
81 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
April 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2031
February 10, 2026
February 1, 2026
12.2 years
December 11, 2018
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of Participants with One or More Serious Adverse Event(s) (SAEs)
Number of participants with one or more SAEs
Baseline through Week 264
Number of Participants with Permanent Investigational Product Discontinuations
Number of participants with permanent investigational product discontinuations
Baseline through Week 264
Secondary Outcomes (13)
Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
Week 264
Proportion of Participants who have Disease Flare
Baseline through Week 264
Proportion of Participants with Inactive Disease
Week 264
Proportion of Participants with Minimal Disease Activity
Week 264
Proportion of Participants in Remission
Week 264
- +8 more secondary outcomes
Study Arms (1)
Baricitinib
EXPERIMENTALBaricitinib given orally.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have completed a previous study of baricitinib for the treatment of JIA.
You may not qualify if:
- Participants must not have had a permanent discontinuation of baricitinib in the prior study.
- Participants must have not developed an allergy to baricitinib.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (82)
Instituto CAICI SRL
Rosario, S2000, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, T4000AXL, Argentina
Royal Children's Hospital
Melbourne, 3052, Australia
Perth Children's Hospital
Perth, 6009, Australia
The Children's Hospital at Westmead
Westmead, 2145, Australia
Landeskrankenhaus Bregenz
Bregenz, 6900, Austria
Cliniques universitaires Saint-Luc
Brussels, 1200, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven
Leuven, 3000, Belgium
Faculdade de Medicina da UNESP
Botucatu, 18618-686, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, 90035-903, Brazil
IPITEC
São Paulo, 01221-020, Brazil
Universidade Federal de Sao Paulo
São Paulo, 04024-002, Brazil
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, 05403-000, Brazil
Beijing Children's hospital, Capital Medical University
Beijing, 100045, China
The Children's Hospital of Chongqing Medical University
Chongqing, 400065, China
Childrens Hospital of Nanjing Medical University
Nanjing, 210008, China
Children's Hospital of Soochow University
Suzhou, 215025, China
Detska nemocnice FN Brno
Brno, 613 00, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 12808, Czechia
Fakultni nemocnice Motol
Prague, 150 06, Czechia
Aarhus Universitetshospital, Skejby
Aarhus, 8200, 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
Hôpital Universitaire Necker Enfants Malades
Paris, 75015, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, 86021, France
Helios Klinikum Berlin-Buch
Berlin, 13125, Germany
Charité Campus Virchow-Klinikum
Berlin, 13353, Germany
Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari
Hamburg, 22081, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69115, Germany
Asklepios Klinik Sankt Augustin
Sankt Augustin, 53757, Germany
Universitaetsklinikum Tuebingen
Tübingen, 72076, Germany
Sri Ramachandra MedicaL College & Research Institute
Chennai, 600116, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Christian Medical College Vellore
Vellore, 632004, India
Rambam Health Care Campus
Haifa, 3109601, Israel
Meir Medical Center
Kfar Saba, 4428164, Israel
Schneider Children's Medical Center
Petah Tikva, 49202, Israel
Sheba Medical Center
Ramat Gan, 5262100, Israel
Azienda Ospedaliera Spedali Civili di Brescia
Brescia, 25123, Italy
Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti
Chieti, 66100, Italy
IRCCS Istituto Giannina Gaslini
Genova, 16147, Italy
Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO
Milan, 20122, Italy
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
University of Naples Federico II
Naples, 80131, Italy
Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli
Palermo, 90127, Italy
Ospedale Infantile Burlo Garofolo
Trieste, 34137, Italy
Institute of Science Tokyo Hospital
Bunkyō, 113-8519, Japan
Chiba Children's Hospital
Chiba, 266-0007, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Kanazawa University Hospital
Kanazawa, 920-8641, Japan
Niigata University Medical & Dental Hospital
Niigata, 951-8520, Japan
Saitama Children's Medical Center
Saitama-shi, 330 8777, Japan
Miyagi Children's Hospital
Sendai, 989-3126, Japan
Tokyo Women's Medical University Hospital
Shinjuku-ku, 162-8666, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, 569-8686, Japan
Kanagawa Children's Medical Center
Yokohama, 232-8555, Japan
Yokohama City University Hospital
Yokohama, 236-0004, Japan
Investigacion y Biomedicina de Chihuahua
Chihuahua City, 31000, Mexico
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000, Mexico
Crea de Guadalajara
Guadalajara, 44600, Mexico
Clinstile, S.A. de C.V.
México, 6700, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, 66460, Mexico
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, 31-503, Poland
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, 91-738, Poland
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, 02-637, Poland
Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova
Moscow, 115522, Russia
Scientific Center of Children's Health
Moscow, 119991, Russia
Hospital Sant Joan de Déu
Esplugues de Llobregat, 8950, 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 Virgen Del Rocio
Seville, 41013, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, 34098, Turkey (Türkiye)
9 Eylul University Hospital
Izmir, 35340, Turkey (Türkiye)
Bristol Royal Hospital for Children
Bristol, BS2 8BJ, United Kingdom
Alder Hey Children's Hospital
Liverpool, L14 5AB, United Kingdom
Great Ormond Street Hospital For Children NHS Foundation Trust
London, WC1N 3JH, United Kingdom
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, OX3 7LD, United Kingdom
Sheffield Children's Hospital
Sheffield, S10 2TH, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST
Eli Lilly and Company
Central Study Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
CONTACT
Physicians interested in becoming principal investigators please contact
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2018
First Posted
December 12, 2018
Study Start
April 5, 2019
Primary Completion (Estimated)
July 1, 2031
Study Completion (Estimated)
July 1, 2031
Last Updated
February 10, 2026
Record last verified: 2026-02
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.