A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With systemic juvenile idiopathic arthritis (sJIA)
- Conditions
- Health Condition 1: M082- Juvenile rheumatoid arthritis withsystemic onset
- Registration Number
- CTRI/2022/03/040770
- Lead Sponsor
- Pfizer Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to sJIA disease flare in the double-blind phase <br/ ><br>Timepoint: Up to 82 weeks after randomization
- Secondary Outcome Measures
Name Time Method