At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
EFFICACY, SAFETY AND TOLERABILITY OF TOFACITINIB FOR TREATMENT OF POLYARTICULAR COURSE JUVENILE IDIOPATHIC ARTHRITIS (JIA) IN CHILDREN AND ADOLESCENT SUBJECTS
In Brief
A Phase 3 clinical trial evaluating CP-690,550 (tofacitinib) and placebo for Juvenile Idiopathic Arthritis. Completed, enrolled 225 participants across 103 sites in 14 countries.
Detailed Summary
Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.
Study Details
Timeline
Interventions
During the open label run in phase, all subjects will receive active tofacitinib oral tablets or oral solution twice daily (BID) orally, at a dosage based on the subject's body weight as specified below. During the double blind, placebo controlled phase, subjects will receive either active tofacitinib oral tablets/oral solution or matching placebo oral tablets/oral solution, twice daily (BID), at a dosage specified below. Body Weight (Dosage in tablet \[BID\] or solution \[BID\]): 5\<7kg (2mg or 2mL); 7\<10kg(2.5mg or 2. mL); 10 \<15kg (3mg or 3mL); 15\<25kg (3.5mg or 3.5mL); 25\<40kg (4mg or 4mL); 40kg (5 mg or 5 ml). Oral solution (1 mg/mL) is used for subjects \<40 kg. Oral tablets (5 mg) are used for subjects \>=40 kg.
matching placebo tablet or solution for tofacitinib