A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

  • STATUS
    Recruiting
  • End date
    Nov 8, 2024
  • participants needed
    100
  • sponsor
    Pfizer
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Updated on 11 April 2023
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Summary

A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. Once 31 flares are reported the study will be completed.

Details
Condition Arthritis Juvenile Idiopathic
Treatment In open-label phase: treatment with tofacitinib, In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Clinical Study IdentifierNCT03000439
SponsorPfizer
Last Modified on11 April 2023

Eligibility

 Yes No Not Sure

Inclusion Criteria

active sJIA disease according to ILAR criteria before screening and at baseline (Day 1)
Treatment with stable doses of methotrexate (MTX) ≤25 mg/week or ≤20 mg/m2/week, whichever is lower, is permitted
Treatment with a stable dose of oral prednisone ≤1 mg/kg/day up to a maximum of 30 mg/day, or equivalent, for at least 1 week before the first study drug dose is permitted

Exclusion Criteria

Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib
Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with systemic juvenile idiopathic arthritis (sJIA). Current symptoms or findings of more than minimal pleuritis with sJIA
Current infection or serious infection within 3 months of study enrollment
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