CTRI/2022/03/040770
Recruiting
Phase 3
Efficacy, safety, tolerability and pharmacokinetics of tofacitinib for treatment of systemic juvenile idiopathic arthritis (sJIA) with active systemic features in children and adolescent subjects
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Health Condition 1: M082- Juvenile rheumatoid arthritis withsystemic onset
- Sponsor
- Pfizer Inc
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Active sJIA disease according to ILAR criteria before screening and at baseline (Day 1\);
- •Treatment with stable doses of methotrexate (MTX) ââ?°Â¤25 mg/week or ââ?°Â¤20 mg/m2/week, whichever is lower, is permitted;
- •Treatment with a stable dose of oral prednisone ââ?°Â¤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.
Outcomes
Primary Outcomes
Not specified
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