Clinical trial Recruiting at 46 sites Phase 3 Interventional Ages 1 Year to 18

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.

More Juvenile Idiopathic Arthritis trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages1 Year to 18 Years
SexAll
Enrollment190 (estimated)
SponsorEli Lilly and Company
Industry-sponsored
Drugs / interventionsbaricitinib
Locations77 sites (Rosario and 76 other locations)
StatusRecruiting
StartedApril 5, 2019
Main results expectedJuly 2031
Study endsJuly 2031
Registry record updatedNovember 4, 2026
Trial IDNCT03773965 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.