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

  • STATUS
    Recruiting
  • End date
    Aug 7, 2023
  • participants needed
    103
  • sponsor
    Eli Lilly and Company
Updated on 24 October 2021

Summary

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).

Details
Condition Systemic Juvenile Idiopathic Arthritis
Treatment Placebo, Baricitinib
Clinical Study IdentifierNCT04088396
SponsorEli Lilly and Company
Last Modified on24 October 2021

Eligibility

Yes No Not Sure

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 arthritis in 1 or more joints with or preceded by fever of at least 2 weeks' duration that is documented to be daily (quotidian) fever for at least 3 days, and accompanied by 1 or more of the following
Evanescent (nonfixed) erythematous rash
Generalized lymph node enlargement
Hepatomegaly and/or splenomegaly
Serositis
Participants must have at least 2 active joints at screening and baseline

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, such as Crohn's disease or ulcerative colitis
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)
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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