Efficacy Study Of Tofacitinib In Pediatric JIA Population

Conditions

• Juvenile Idiopathic Arthritis

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• CP-690,550 (tofacitinib) — DRUG
  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.
• placebo — OTHER
  matching placebo tablet or solution for tofacitinib

Study Details

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

Key Dates

Start date

Jun 10, 2016

Status verified

Mar 2020

Primary completion

May 16, 2019

Completion

May 16, 2019

Study Design

Enrollment

225 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: CP-690,550
  Treatment arm: Tofacitinib tablets or solution, according to subjects' body weights
• Placebo Comparator: Placebo
  Control arm: matching placebo tablets or solution for tofacitinib

Primary Outcome Measure

Double Blind Phase: Percentage of Participants With Disease Flare According to Pediatric Rheumatology Collaborative Study Group/Pediatric Rheumatology International Trials Organization (PRCSG/PRINTO) Disease Flare Criteria at Week 44 [ Time Frame: Week 44 ]

Locations (55)

Find similar trials in Little Rock, AR

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