A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Ac… (NCT04088409) | Clinical Trial Compass
Active — Not RecruitingPhase 3
A Study of Baricitinib (LY3009104) in Participants From 2 Years to Less Than 18 Years Old With Active JIA-Associated Uveitis or Chronic Anterior Antinuclear Antibody-Positive Uveitis
France, Germany30 participantsStarted 2019-10-16
Plain-language summary
The reason for this study is to see if the study drug baricitinib given orally is safe and effective in participants with active juvenile idiopathic arthritis (JIA)-associated uveitis or chronic anterior antinuclear antibody-positive uveitis from 2 years to less than 18 years old.
Who can participate
Age range2 Years – 17 Years
SexALL
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Inclusion Criteria:
* Participants must have a diagnosis of JIA-U or chronic anterior antinuclear antibody (ANA) positive uveitis without systemic features.
* Participants must have active anterior uveitis, defined as cellular infiltrate in the anterior chamber of SUN criteria grade ≥1+ at screening and randomization, despite prior treatment with adequate doses of topical steroid therapy and methotrexate (MTX).
* Participants must have an inadequate response or intolerance to MTX.
* Participants must be on a stable dose of corticosteroid eye drops for at least 2 weeks prior to screening with a maximum of 4 drops/day/eye at screening.
* Participants and their partners of child bearing potential must agree to use 2 effective methods of contraception for the duration of the study and for at least 1 week following the last dose of investigational product.
Exclusion 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 any contraindications to adalimumab.
* Exception: Participants who are biologic disease-modifying antirheumatic drug (bDMARD) inadequate response or intolerance with a contraindication to adalimumab may be enrolled, as they will be assigned to baricitinib.
* Participants must not have increased intraocular pressure ≥25 millimeters of mercury (mm Hg) or that required treatment, including increases in medications, surgery, o…
What they're measuring
1
Part A: Percentage of Responders for Baricitinib at Week 24