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Xeljanz A3921165

Trial

Clinical Trial Title

Xeljanz A3921165

Trial Status

Open to Enrollment

Start Date

November 1, 2017

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

Principal Investigator Name

Daniel Kingsbury, MD

Contact Name

Kristini Hickey

Phone

503-413-5447

Contact Fax

503-413-3543

Contact E-Mail

khickey@lhs.org

Last Updated: Friday, November 3, 2017 04:01:35 PM