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Evaluating Baricitinib for Children with Systemic Juvenile Idiopathic Arthritis

Open-Label, Randomized Study With a Tocilizumab Reference Arm to Evaluate Safety, Efficacy and Pharmacokinetics of Baricitinib in Children From 1 to Less Than 18 Years of Age With Systemic Juvenile Idiopathic Arthritis.

Phase 3 Interventional Eli Lilly and Company · NCT04088396

This study tests whether the medication baricitinib can help children with systemic juvenile idiopathic arthritis manage their symptoms and improve their joint health.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment58 (estimated)
Ages1 Year to 17 Years
SexAll
SponsorEli Lilly and Company Industry-sponsored
Drugs / interventionstocilizumab, baricitinib
Locations55 sites (Rosario and 54 other locations)
Trial IDNCT04088396 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 diagnosed with systemic juvenile idiopathic arthritis (sJIA). Participants are divided into two cohorts: one receiving baricitinib or tocilizumab, and the other receiving baricitinib alone. The study aims to assess the drug's impact on active joint inflammation and overall disease management in this pediatric population.

Who should consider this trial

Good fit: Ideal candidates are children aged 1 to less than 18 years with a confirmed diagnosis of systemic juvenile idiopathic arthritis and at least two active joints.

Not a fit: Patients with other forms of juvenile idiopathic arthritis, such as polyarticular or oligoarticular JIA, are unlikely to benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the management of systemic juvenile idiopathic arthritis in children, potentially leading to better long-term outcomes.

How similar studies have performed: Other studies have shown promise in using similar biologic therapies for juvenile idiopathic arthritis, indicating a potential for success with this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Participants must have a diagnosis of systemic Juvenile Idiopathic Arthritis (sJIA) as defined by International League of Associations for Rheumatology (ILAR) criteria with onset before the age of 16 years
* Participants must have at least 2 active joints at screening and baseline
* Cohort 1 (IL-6 inhibitor therapy naive): Participants who are at least 1 year and less than 18 years of age, except in countries that restrict use of tocilizumab in participants less than 2 years of age
* Cohort 2 (open-label baricitinib): Participants who are at least 1 year and less than 18 years of age

Exclusion Criteria:

* Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis
* Participants must not have persistent oligoarticular arthritis as defined by the ILAR criteria
* Participants must not have a history or presence of any autoimmune inflammatory condition other than JIA
* Participants must not have active anterior uveitis or are receiving concurrent treatment for anterior uveitis
* Participants must not have active fibromyalgia or other chronic pain conditions that, in the investigator's opinion, would make it difficult to appropriately assess disease activity for the purposes of this study
* Participants must not have biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks
* Participants must not have a current or recent (\<4 weeks prior to baseline) clinically serious infection
* Participants must not have a positive test for hepatitis B virus
* Participants must not have evidence of active tuberculosis (TB) or untreated latent TB

Where this trial is running

Rosario and 54 other locations

+5 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Systemic Juvenile Idiopathic ArthritisSystemicFeverFlaresJIAJIA
Last reviewed 2026-06-13 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.