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Janus Kinase (JAK) Inhibitor

Tofacitinib for Juvenile Idiopathic Arthritis

Phase 3
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Active sJIA disease according to ILAR criteria before screening and at baseline (Day 1)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 3, day 7, day 14
Awards & highlights

Study Summary

This trial will test whether the drug tofacitinib can help prevent sJIA flares.

Who is the study for?
This trial is for pediatric patients with active systemic Juvenile Idiopathic Arthritis (sJIA) who meet specific criteria. They can be taking a stable dose of oral prednisone and methotrexate. However, they cannot join if they have current infections, serious recent infections, previous treatment with tofacitinib, or certain heart or lung complications related to sJIA.Check my eligibility
What is being tested?
The study tests the safety and effectiveness of Tofacitinib in children with sJIA. Initially, all participants receive Tofacitinib openly. Responders then enter a second phase where they're randomly given either Tofacitinib or a placebo without knowing which one. The main focus is on how long it takes for their sJIA symptoms to worsen ('flare').See study design
What are the potential side effects?
Tofacitinib may cause side effects such as increased risk of infections due to its impact on the immune system, potential liver issues reflected by blood test changes, headaches, diarrhea and high blood pressure. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My juvenile arthritis is active according to specific criteria.
Select...
I have been on a stable dose of prednisone or equivalent, up to 30 mg/day, for at least a week.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 3, day 7, day 14
This trial's timeline: 3 weeks for screening, Varies for treatment, and day 3, day 7, day 14 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time to flare
Secondary outcome measures
"Absence of fever", defined as absence of fever due to sJIA in the week preceding the assessment at every visit from Day 7 onward in the open label and double blind phase.
Achievement of a corticosteroid dose of 0.2 mg/kg/day or 10 mg/day (whichever is lower) at the end of the open label treatment period
Achievement of corticosteroid tapering at the end of the open-label phase
+11 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Tofacitinib 5 mg BIDExperimental Treatment2 Interventions
oral, twice daily, tablet or solution.
Group II: PlaceboPlacebo Group1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
In open-label phase: treatment with tofacitinib
2018
Completed Phase 3
~100
In double-blind phase: treatment with tofacitinib or placebo in 1:1 ratio
2018
Completed Phase 3
~100

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,583 Previous Clinical Trials
14,635,433 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,488 Previous Clinical Trials
11,812,384 Total Patients Enrolled

Media Library

Juvenile Idiopathic Arthritis Clinical Trial 2023: Tofacitinib Highlights & Side Effects. Trial Name: NCT03000439 — Phase 3
Tofacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03000439 — Phase 3
~14 spots leftby Jun 2025
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