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A Study of Baricitinib (LY3009104) in Participants From 1 Year to Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (sJIA)

View on ClinicalTrials.gov ↗

At a glance

What the study gets you: Access to the study treatment being tested
Type of study: Interventional (receives a drug or procedure)
Time in hospital: In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention: Baricitinib (drug), Tocilizumab (drug)
How long the study runs: Study runs about 80 months (dates as stated)
About the drug or intervention: Baricitinib — drug: Administered orally · Tocilizumab — drug: Administered SC
Patient visit burden: Not specified by the sponsor

Type of study: Testing a treatment
Ages: 1 Year to 17 Years
Who: All
Number of participants: 58
Started: 2020-02-12
Last checked: 2026-08

Plain English Summary

What is this study?

• Testing a new treatment for systemic juvenile idiopathic arthritis
• Phase3 - 58 participants
• The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA)

Who can take part?

• Ages 1 Year to 17 Years
• Diagnosed with systemic juvenile idiopathic arthritis

Where?

• Bristol - Bristol Royal Hospital for Children
• Liverpool - Alder Hey Children's Hospital
• London - Great Ormond Street Hospital For Children NHS Foundation Trust
• Oxford - Oxford University Hospitals - Nuffield Orthopaedic Centre
• +1 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

The reason for this study is to see if the study drug baricitinib is safe and effective in participants from 1 year to less than 18 years old with systemic juvenile idiopathic arthritis (sJIA). Participants are assigned to 1 of 2 cohorts. In cohort 1, participants will receive baricitinib or tocilizumab reference. In cohort 2, participants will receive baricitinib.

Systemic Juvenile Idiopathic Arthritis

How this trial compares with your answers

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What we know so far

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

Age: 1 Year - 17 Years
Who can join: All genders

Biomarkers mentioned

positive or negativehave a positive

Treatment history

Treatments you must have had:

✓ at least 2 active joints at screening and baseline

What the study is looking for

✓Participants must have at least 2 active joints at screening and baseline
✓Cohort 2 (everyone knows which treatment they get baricitinib): Participants who are at least 1 year and less than 18 years of age

Who cannot take part

✗Participants must not have polyarticular JIA (positive or negative for rheumatoid factor), extended oligoarticular...
✗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 biologic features of Macrophage Activation Syndrome (MAS) over the past 12 weeks

See the full 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