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Janus Kinase (JAK) Inhibitor

Tofacitinib for Juvenile Arthritis

Phase 2 & 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
Be younger than 65 years old
Must not have
A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
Persistent oligoarthritis and undifferentiated JIA.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial will evaluate the long-term safety and tolerability of tofacitinib in patients with juvenile idiopathic arthritis (JIA) who have previously participated in tofacitinib JIA studies.

Who is the study for?
This trial is for pediatric patients aged 2 to less than 18 with Juvenile Idiopathic Arthritis (JIA) who've been in previous tofacitinib studies. They should have active JIA needing treatment and use effective contraception if applicable. Excluded are those with recent serious infections, certain viral infections like HIV or hepatitis, recurrent herpes zoster, or chronic infections.
What is being tested?
The study tests the long-term safety of a medication called Tofacitinib in young patients with JIA. It's for those who've already taken part in earlier Tofacitinib trials and focuses on how well they tolerate the drug over an extended period.
What are the potential side effects?
Tofacitinib may cause side effects such as increased risk of infections, headaches, diarrhea, inflammation of the nasal passage and upper pharynx, vomiting, and abdominal pain. Long-term use might also affect liver enzymes and blood cell counts.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I am infected with HIV, hepatitis B, or hepatitis C.
Select...
I have long-lasting arthritis in few joints and a type of juvenile arthritis.
Select...
I have had shingles more than once or a widespread herpes simplex infection.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Side effects data

From 2017 Phase 3 trial • 209 Patients • NCT02281552
10%
Nasopharyngitis
2%
Pneumocystis jirovecii pneumonia
1%
Rectal cancer
1%
Pneumonia
1%
Femoral neck fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib Modified Release (MR)
Tofacitinib Immediate Release (IR)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: TofacitinibExperimental Treatment1 Intervention
All patients will be in tofacitinib treatment group.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tofacitinib
2018
Completed Phase 4
~32260

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,649 Previous Clinical Trials
17,744,095 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,536 Previous Clinical Trials
14,915,283 Total Patients Enrolled

Media Library

Tofacitinib (Janus Kinase (JAK) Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT01500551 — Phase 2 & 3
Juvenile Idiopathic Arthritis Research Study Groups: Tofacitinib
Juvenile Idiopathic Arthritis Clinical Trial 2023: Tofacitinib Highlights & Side Effects. Trial Name: NCT01500551 — Phase 2 & 3
Tofacitinib (Janus Kinase (JAK) Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01500551 — Phase 2 & 3
~6 spots leftby Feb 2025
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