Efficacy Study Of Tofacitinib In Pediatric JIA Population
Condition: Juvenile Idiopathic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      Evaluate efficacy, safety and tolerability of tofacitinib in pediatric JIA patients.
    

Detailed description: 
      This is a randomized withdrawal, double blind, placebo controlled study of pediatric subjects
      (2 to <18 years of age) with JIA. The primary objective is to compare the efficacy of
      tofacitinib versus placebo for the treatment of signs and symptoms of JIA at Week 26 of the
      double blind phase as measured by the percentage of subjects with disease flare (according to
      PRCSG/PRINTO Disease Flare criteria) after Week 18 of the open label run in phase.All
      eligible subjects enrolled in the study will initially receive open label tofacitinib for 18
      weeks (run in phase). At the end of the 18 week run in phase, only subjects who achieve at
      least a JIA ACR 30 response will be randomized to the 26 week double blind, placebo
      controlled phase. Subjects who do not achieve a JIA ACR 30 response at this time point will
      be discontinued from the study. In addition, subjects who experience a single episode of
      disease flare at any time during the study (including the open label run in and double blind
      phase) will also be discontinued from the study. All subjects participating in this study,
      including those discontinued from the study, will have the option, if eligible (based on
      inclusion and exclusion criteria), of enrolling in the tofacitinib JIA long term extension
      study (A3921145).

      Subjects who are eligible for the 26 week double blind phase will be randomized (1:1 ratio)
      to either active tofacitinib or placebo. For subjects with polyarticular course JIA (ie,
      extended oligoarthritis, polyarthritis RF+, polyarthritis RF , systemic JIA with active
      arthritis but without active systemic features), randomization will be stratified by JIA
      category and baseline CRP (normal, above normal). For subjects with psoriatic and enthesitis
      related arthritis, randomization will be stratified by JIA category.

      Approximately 210 subjects will be enrolled in the open label run in phase. Among subjects
      with polyarticular course JIA, stratification will target at least 50% with a baseline CRP
      above the upper limit of normal. The first cohort (ie, polyarticular course JIA) will have at
      least 170 subjects enrolled in the run in phase with the minimum number of JIA categories as
      follows: 24 with extended oligoarthritis, 20 with polyarthritis RF+, 62 with polyarthritis
      RF-, and no minimum for subjects with systemic JIA with active arthritis but without active
      systemic features. Additional cohorts (ie, psoriatic and enthesitis related arthritis) will
      include a minimum of 20 subjects with psoriatic arthritis, and 20 subjects with enthesitis
      related arthritis. The overall target minimum number of subjects to be enrolled in the study
      by age is as follows: 20 subjects 2 to <6 years, 20 subjects 6 to <12 years, and 20 subjects
      12 to <18 years. The duration of subject participation among those who complete the study
      (without discontinuation) is expected to be approximately 44 weeks.
    

Intervention name(s): CP-690,550 (tofacitinib); placebo
Intervention type(s): Drug; Other
Intervention description(s): 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
Other intervention name(s): Matching placebo to tofacitinib (same tablet or solution as the active arm).; Placebo for tofacitinib
Intervention MeSH terms: Tofacitinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis; Pediatric; Long-term; JIA; polyarticular; CP-690,550; tofacitinib; Xeljanz