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 3Interventional 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?
Answer a few quick questions to see if you may meet the eligibility requirements.
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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Status
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…
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
Contacts
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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