A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

Conditions

• Arthritis Juvenile Idiopathic

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• In open-label phase: treatment with tofacitinib — DRUG
  Treatment with investigational drug
• In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio — DRUG
  Treatment with investigational drug or placebo

Study Details

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. An interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. If either criterion is met, the study will be stopped. If neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.

Key Dates

Start date

May 10, 2018

Status verified

May 2025

Primary completion

Mar 27, 2024

Completion

Mar 27, 2024

Study Design

Enrollment

100 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Tofacitinib 5 mg BID
  oral, twice daily, tablet or solution.
• Placebo Comparator: Placebo

Primary Outcome Measure

Time to Systemic Juvenile Idiopathic Arthritis (sJIA) Disease Flare: Double-Blind Phase [ Time Frame: From randomization up to 248 weeks ]

Locations (5)

Related coverage on Hipa.ai

• Tofacitinib Trial Results Posted for Systemic Juvenile Idiopathic Arthritis
  Tofacitinib · Jun 3, 2025 · ClinicalTrials.gov

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