Tofacitinib for JIA A3921165

Clinical Trial Title A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Trial Status Open to Enrollment
Start Date 11/01/2017
Location randall-childrens-hospital-at-legacy-emanuel
Trial Type Pediatric Rheumatology
Specific Condition Systemic Juvenile Idiopathic Arthritis
Description

A Randomized Double Blind Placebo Controlled Study To Evaluate Efficacy And Safety Of Cp-690,550 In Children From 2 To Less Than 18 Years Old With Systemic Juvenile Idiopathic Arthritis (Jia) With Active Systemic Features

A randomized withdrawal study in which responders to open-label treatment with tofacitinib will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects will be discontinued once they experience sJIA flare. Once 31 flares are reported the study will be completed.

 
Eligibility Criteria
Ages Eligible for Study: 2 Years to 17 Years (Child)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria

Inclusion Criteria:

  • active sJIA disease according to ILAR criteria for at least 6 weeks before screening
  • 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:

  • Previous JIA treatment with tofacitinib;
  • 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.
IRB Number 10810
Notes https://clinicaltrials.gov/ct2/show/NCT03000439
Principal Investigator Daniel Kingsbury, MD
Contact Name Kristin Hickey
Contact Phone 503-413-5447
Contact Fax 503-413-3543
Contact E-Mail khickey@lhs.org