Evaluating baricitinib for treating juvenile idiopathic arthritis in children
Official title: 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)
Run by Eli Lilly and Company · NCT03773965 · Data updated 2026-11-12
This study tests if continuing treatment with baricitinib helps children with juvenile idiopathic arthritis feel better and stay safe.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Enrollment | 190 (estimated) |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | baricitinib |
| Locations | 77 sites (Rosario and 76 other locations) |
| Status | Recruiting |
| Started | April 5, 2019 |
| Main results expected | July 2031 |
| Study ends | July 2031 |
| Registry record updated | November 4, 2026 |
| Trial ID | NCT03773965 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 1 to less than 18 years who have previously participated in baricitinib studies for JIA.
✕Probably not a fit
Patients who have had a permanent discontinuation of baricitinib or developed an allergy to it will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the safety and effectiveness of baricitinib in children aged 1 to less than 18 years who have juvenile idiopathic arthritis (JIA). Participants must have previously completed a study involving baricitinib and cannot have had a permanent discontinuation of the drug. The study aims to build on prior findings to determine if continued treatment is beneficial for this age group. The focus is on various forms of JIA, including polyarticular and systemic types.
Why it matters
Potential benefit: If successful, this study could provide a new effective treatment option for children suffering from juvenile idiopathic arthritis.
How similar studies have gone: Previous studies involving baricitinib for JIA have shown promising results, indicating potential success for this approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participants must have completed a previous study of baricitinib for the treatment of JIA. Exclusion Criteria: * Participants must not have had a permanent discontinuation of baricitinib in the prior study. * Participants must have not developed an allergy to baricitinib.
Where it's running
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UZ Gent
Ghent, Belgium Recruiting -
UZ Leuven
Leuven, Belgium Recruiting -
Faculdade de Medicina da UNESP
Botucatu, Brazil Recruiting -
Universidade Federal de Sao Paulo
São Paulo, Brazil Recruiting -
Instituto da Crianca do Hospital das Clinicas da FMUSP
São Paulo, Brazil Recruiting -
Detska nemocnice FN Brno
Brno, Czechia Recruiting
Show 44 more locations
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Vseobecna fakultni nemocnice v Praze
Prague, Czechia Recruiting -
Fakultni nemocnice Motol
Prague, Czechia Recruiting -
Aarhus Universitetshospital, Skejby
Aarhus, Denmark Recruiting -
Hospices Civils de Lyon - Hôpital Femme Mère Enfant
Bron, France Recruiting -
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, France Recruiting -
Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau
Nîmes, France Recruiting -
Hôpital Universitaire Necker Enfants Malades
Paris, France Recruiting -
Centre Hospitalier Universitaire de Poitiers
Poitiers, France Recruiting -
Sir Ganga Ram Hospital
New Delhi, India Recruiting -
Christian Medical College Vellore
Vellore, India Recruiting -
Rambam Health Care Campus
Haifa, Israel Recruiting -
Meir Medical Center
Kfar Saba, Israel Recruiting -
Schneider Children's Medical Center
Petah Tikva, Israel Recruiting -
Sheba Medical Center
Ramat Gan, Israel Recruiting -
Institute of Science Tokyo Hospital
Bunkyō, Japan Recruiting -
Kagoshima University Hospital
Kagoshima, Japan Recruiting -
Niigata University Medical & Dental Hospital
Niigata, Japan Recruiting -
Saitama Children's Medical Center
Saitama-shi, Japan Recruiting -
Miyagi Children's Hospital
Sendai, Japan Recruiting -
Tokyo Women's Medical University Hospital
Shinjuku-ku, Japan Recruiting -
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Japan Recruiting -
Kanagawa Children's Medical Center
Yokohama, Japan Recruiting -
Yokohama City University Hospital
Yokohama, Japan Recruiting -
Investigacion y Biomedicina de Chihuahua
Chihuahua City, Mexico Recruiting -
Instituto de Investigaciones Clínicas para la Salud
Durango, Mexico Recruiting -
Crea de Guadalajara
Guadalajara, Mexico Recruiting -
Clinstile, S.A. de C.V.
México, Mexico Recruiting -
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Mexico Recruiting -
Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie
Krakow, Poland Recruiting -
Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi
Lodz, Poland Recruiting -
Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji
Warsaw, Poland Recruiting -
Hospital Sant Joan de Déu
Esplugues de Llobregat, Spain Recruiting -
Hospital Universitario Ramón y Cajal
Madrid, Spain Recruiting -
Hospital Universitario La Paz
Madrid, Spain Recruiting -
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Turkey (Türkiye) Recruiting -
Bristol Royal Hospital for Children
Bristol, United Kingdom Recruiting -
Alder Hey Children's Hospital
Liverpool, United Kingdom Recruiting -
Great Ormond Street Hospital For Children NHS Foundation Trust
London, United Kingdom Recruiting -
Oxford University Hospitals - Nuffield Orthopaedic Centre
Oxford, United Kingdom Recruiting -
Sheffield Children's Hospital
Sheffield, United Kingdom Recruiting -
Instituto CAICI SRL
Rosario, Argentina Active not recruiting -
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Argentina Active not recruiting -
Royal Children's Hospital
Melbourne, Australia Not yet recruiting -
Perth Children's Hospital
Perth, Australia Not yet recruiting
+27 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
- Email: LillyTrials@Lilly.com
- Phone: 1-317-615-4559
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Using infrared cameras to help detect juvenile arthritis in kids
This study tests whether infrared thermography can help identify joint inflammation in children with juvenile idiopathic arthritis compared with standard tests.
-
Safety and drug level study of multiple doses of upadacitinib, tofacitinib, and baricitinib in healthy adults
This early-phase study tests how different doses of upadacitinib, tofacitinib, and baricitinib behave in healthy adults to understand safety and how the drugs act in the body.
-
Oral health, saliva bacteria, and disease activity in children with JIA
This study checks if how active juvenile idiopathic arthritis is relates to oral health in children who already receive rheumatology care.
-
Baricitinib for persistent low platelets after stem cell transplant
We’re testing baricitinib to see if it can help people with long-term low platelets after an allogeneic stem cell transplant who didn’t respond to other treatments.
-
Olokizumab treatment for children with polyarticular juvenile idiopathic arthritis
This test gives weight-based doses of olokizumab every 4 weeks to see if it helps control polyarticular juvenile idiopathic arthritis and is safe for children aged 2–17.
-
Telitacicept plus baricitinib for refractory rheumatoid arthritis
This test tries combining telitacicept with baricitinib to see if it helps adults with refractory rheumatoid arthritis who haven't improved on other treatments.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.