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Efficacy Study Of Tofacitinib In Pediatric JIA Population

NCT02592434 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 225

Last updated 2020-04-13

Study results available
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Summary

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

Conditions

  • Juvenile Idiopathic Arthritis

Interventions

DRUG

CP-690,550 (tofacitinib)

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.

OTHER

placebo

matching placebo tablet or solution for tofacitinib

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-10
Primary Completion
2019-05-16
Completion
2019-05-16

Countries

  • United States
  • Argentina
  • Australia
  • Belgium
  • Brazil
  • Canada
  • Israel
  • Mexico
  • Poland
  • Russia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02592434 on ClinicalTrials.gov