Evaluating baricitinib for treating juvenile idiopathic arthritis in children
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)
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 |
| Enrollment | 190 (estimated) |
| Ages | 1 Year to 18 Years |
| Sex | All |
| Sponsor | Eli Lilly and Company Industry-sponsored |
| Drugs / interventions | baricitinib |
| Locations | 80 sites (Rosario and 79 other locations) |
| Trial ID | NCT03773965 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 1 to less than 18 years who have previously participated in baricitinib studies for JIA.
Not a fit: Patients who have had a permanent discontinuation of baricitinib or developed an allergy to it will not benefit from this study.
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 performed: Previous studies involving baricitinib for JIA have shown promising results, indicating potential success for this approach.
Eligibility criteria
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 this trial is running
Rosario and 79 other locations
- Instituto CAICI SRL — Rosario, Argentina (Recruiting)
- Centro de Investigaciones Médicas Tucuman — SAN M. de Tucuman, Argentina (Recruiting)
- Royal Children's Hospital — Melbourne, Australia (Not_yet_recruiting)
- Perth Children's Hospital — Perth, Australia (Not_yet_recruiting)
- The Children's Hospital at Westmead — Westmead, Australia (Active_not_recruiting)
- Landeskrankenhaus Bregenz — Bregenz, Austria (Completed)
- Cliniques universitaires Saint-Luc — Brussels, Belgium (Completed)
- 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)
- Beijing Children's hospital, Capital Medical University — Beijing, China (Active_not_recruiting)
- The Children's Hospital of Chongqing Medical University — Chongqing, China (Active_not_recruiting)
- Childrens Hospital of Nanjing Medical University — Nanjing, China (Recruiting)
- Children's Hospital of Soochow University — Suzhou, China (Recruiting)
- Detska nemocnice FN Brno — Brno, Czechia (Recruiting)
- 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)
- Helios Klinikum Berlin-Buch — Berlin, Germany (Active_not_recruiting)
- Charité Campus Virchow-Klinikum — Berlin, Germany (Completed)
- Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari — Hamburg, Germany (Active_not_recruiting)
- Universitätsklinikum Heidelberg — Heidelberg, Germany (Completed)
- Asklepios Klinik Sankt Augustin — Sankt Augustin, Germany (Active_not_recruiting)
- Universitaetsklinikum Tuebingen — Tübingen, Germany (Active_not_recruiting)
- Sri Ramachandra MedicaL College & Research Institute — Chennai, India (Completed)
- 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)
- Azienda Ospedaliera Spedali Civili di Brescia — Brescia, Italy (Recruiting)
- Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti — Chieti, Italy (Completed)
- IRCCS Istituto Giannina Gaslini — Genova, Italy (Recruiting)
- Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO — Milan, Italy (Not_yet_recruiting)
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico — Milan, Italy (Completed)
- University of Naples Federico II — Naples, Italy (Recruiting)
- Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli — Palermo, Italy (Not_yet_recruiting)
- Ospedale Infantile Burlo Garofolo — Trieste, Italy (Recruiting)
- Institute of Science Tokyo Hospital — Bunkyō, Japan (Recruiting)
- Chiba Children's Hospital — Chiba, Japan (Recruiting)
- Kagoshima University Hospital — Kagoshima, Japan (Recruiting)
- Kanazawa University Hospital — Kanazawa, Japan (Recruiting)
+30 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.