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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

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,773 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,941 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are patients who are 60 years or older being accepted into this clinical trial?

"According to the eligibility requirements for this research, children as young as 2 and no older than 17 may participate."

Answered by AI

Is tofacitinib approved by the FDA for use in open-label clinical trials?

"In open-label phase: treatment with tofacitinib has received a safety score of 3 from our team at Power. This is based on the fact that it is a Phase 3 trial, meaning there is some evidence for efficacy as well as multiple rounds of data affirming its safety."

Answered by AI

Is tofacitinib being used in any other ongoing research projects?

"University of Nebraska Medical Center first studied tofacitinib in 2007. In the intervening years, 118 completed studies have been conducted with 34 active trials currently underway. A large number of these are based out of Saint Petersburg, Florida."

Answered by AI

What is tofacitinib used for in open-label phase trials?

"The open-label phase of this study will use tofacitinib to treat patients with juvenile arthritis. Tofacitinib can also be used as a last resort for patients that are intolerant to methotrexate or have an inadequate response to other forms of therapy."

Answered by AI

Are there any specific qualifications that potential participants must meet?

"This study is looking for 100 child participants that suffer from juvenile arthritis. These individuals must be aged 2-17 and meet the following criteria: active sjia disease according to ILAR criteria before screening and at baseline (Day 1);, 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.."

Answered by AI

Are there any open slots left in this trial for new participants?

"The most recent information on clinicaltrials.gov supports that this study is still recruiting patients. This trial was initially posted on May 10th, 2018 and edited for the last time on November 3rd, 2022. The research is hoping to enroll 100 individuals from 22 different centres."

Answered by AI

Who else is applying?

What state do they live in?
Florida
What site did they apply to?
AdventHealth
What portion of applicants met pre-screening criteria?
Did not meet criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
2018. "A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03000439.
All > SJIA > Xeljanz
~14 spots leftby Apr 2025
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