Health Condition 1: M082- Juvenile rheumatoid arthritis withsystemic onset
Conditions
Interventions
Intervention1: Tofacitinib: 5 mg BID oral, twice daily, tablet or solution In open-label phase: treatment with tofacitinib Treatment with investigational drug. Duration of therapy will be 12 to 40 Wee
Sponsors
Pfizer Inc
Eligibility
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to sJIA disease flare in the double-blind phase Timepoint: Up to 82 weeks after randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| "Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phaseTimepoint: Up to 82 weeks after randomization;Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment periodTimepoint: 12 to 40 weeks;Achievement of corticosteroid tapering at the end of the open-label phaseTimepoint: 12 to 40 weeks;Adapted sJIA ACR 30/50/70/90/100 response at every visit from Day 7 onward in the open label and double blind phaseTimepoint: Up to 82 weeks after randomization;Change from baseline in Child Health Assessment Questionnaire (CHAQ) at every visit from Day 7 onward in the open label and double blind phaseTimepoint: Up to 82 weeks after randomization;Change from baseline in Child Health Questionnaire (CHQ) responses at the end of Part 1 and Part 2 of the open label phase, at randomization and every 3 months thereafterTimepoint: Up to 82 weeks after randomization;Change from baseline in each JIA ACR core variable at every visit from Day 7 onward in the open label and double blind phaseTimepoint: Up to 82 weeks after randomization;Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS 27) at every visit from Day 7 onward in the open label and double blind phaseTimepoint: Up to 82 weeks after randomization;CRP ââ?°Â¤ 10 mg/L at every visit of the open label phaseTimepoint: 12 to 40 weeks;Fever (Temp 38 Degrees Celsius) attributed to sJIA at Day 3, Day 7 and Day 14 of the open label phaseTimepoint: Day 3, Day 7, Day 14;Occurrence of disease flare in double-blind phaseTimepoint: Up to 82 weeks after randomization;Occurrence of inactive disease status and clinical remission at every visit from Day 7 onward (JIA ACR) in the open label and double blind phaseTimepoint: Up to 82 weeks after randomization;Occurrence of inactive disease status and minimal disease activity clinical remission at ever | — |
Countries
Argentina, Belgium, Brazil, Canada, Costa Rica, Germany, Hungary, India, Israel, Italy, Mexico, Netherlands, Poland, Russian Federation, Slovakia, South Africa, Spain, Sweden, Turkey, Ukraine, United Kingdom, United States of America
Contacts
Public ContactDr Seema Pai
Pfizer Limited
Outcome results
None listed