Baricitinib for Systemic Juvenile Idiopathic Arthritis

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

Recruiting Phase 3 Interventional Study
Systemic Juvenile Idiopathic Arthritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
1 – 17
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
58 (estimated)
Sponsor
Eli Lilly and Company · Industry
Who this trial is looking for

This trial is looking for children and teenagers aged 1 to less than 18 years who have systemic juvenile idiopathic arthritis (sJIA). Participants will take either the study drug baricitinib or a comparison treatment and will help researchers learn about the safety and effectiveness of the drug.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with systemic juvenile idiopathic arthritis.
  • I have at least 2 active joints.
  • I am at least 1 year old and less than 18 years old.

You may not be able to join if

  • I have polyarticular JIA or other specified types of JIA.
  • I have a history of any autoimmune inflammatory condition other than JIA.
  • I have active anterior uveitis.
  • I have active fibromyalgia or other chronic pain conditions.
  • I have had a serious infection in the last 4 weeks.
  • I have a positive test for hepatitis B.
  • I have evidence of active tuberculosis or untreated latent TB.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

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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.

Trial Locations
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Eligibility 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 base…
Contacts

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

1-317-615-4559

LillyTrials@Lilly.com

CONTACT

Physicians interested in becoming principal investigators please contact

clinical_inquiry_hub@lilly.com

CONTACT