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

  • End date
    Mar 11, 2024
  • participants needed
  • sponsor
Updated on 4 September 2021
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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.

Treatment In open-label phase: treatment with tofacitinib, In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
Clinical Study IdentifierNCT03000439
Last Modified on4 September 2021


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 JIA treatment with tofacitinib, baricitinib, or any other JAK-inhibitor
Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with sJIA. Current symptoms or findings of more than minimal pleuritis with sJIA
Subjects who have previously failed treatment with more than two biologic DMARDs. Note: all subjects will be allowed to have previously failed one biologic DMARD, and up to forty (40) percent of subjects will be allowed to have previously failed two biologic DMARDs provided that washout periods are respected
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