Actively Recruiting
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 With Systemic Juvenile Idiopathic Arthritis
Led by Eli Lilly and Company · Updated on 2026-02-10
58
Participants Needed
55
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of the drug baricitinib in children aged 1 to less than 18 years who have systemic juvenile idiopathic arthritis sJIA. This study is a Phase 3 trial that compares baricitinib with tocilizumab in one group and evaluates baricitinib alone in another group. The goal is to understand how these treatments work for young patients with active joint disease due to sJIA. Participants are divided into two groups Cohort 1 includes children who have not previously received IL-6 inhibitor therapy and are randomly assigned to receive either oral baricitinib or subcutaneous tocilizumab. Cohort 2 includes children who receive oral baricitinib without comparison. Treatments are given over several weeks, with key assessments planned at Week 12 and Week 24 to evaluate response and disease activity. Throughout the study, children will be monitored to see how many achieve specific improvements in their arthritis symptoms, measured by adapted pediatric response criteria and disease activity scores. Researchers will also track pain changes and baricitinib levels in the blood. The study involves regular visits for these assessments and safety checks, with participation lasting through Week 24 or longer as planned.
CONDITIONS
Brief Title
A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have a diagnosis of systemic juvenile idiopathic arthritis (sJIA) with onset before age 16, according to ILAR criteria
- Participants must have at least 2 active joints at screening and baseline
- Participants in Cohort 1 must be between 1 and less than 18 years old and not previously treated with IL-6 inhibitors; tocilizumab may be restricted for those under 2 years in some countries
- Participants in Cohort 2 must be between 1 and less than 18 years old
You will not qualify if you...
- Participants with polyarticular JIA, extended oligoarticular JIA, enthesitis-related JIA, or juvenile psoriatic arthritis are excluded
- Participants with persistent oligoarticular arthritis are excluded
- Participants with other autoimmune inflammatory conditions besides JIA are excluded
- Participants with active anterior uveitis or receiving treatment for it are excluded
- Participants with active fibromyalgia or other chronic pain conditions affecting disease assessment are excluded
- Participants with biologic features of Macrophage Activation Syndrome (MAS) in the past 12 weeks are excluded
- Participants with a current or recent (less than 4 weeks prior) serious infection are excluded
- Participants who test positive for hepatitis B are excluded
- Participants with active tuberculosis or untreated latent TB are excluded
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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