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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 8 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 8 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Standard laboratory safety data and adverse event (AE) reports. Body weight, height and Tanner Stages will collected to assess growth and physical development.
Secondary outcome measures
Change from baseline in Juvenile Arthritis Disease Activity Score (JADAS) 27- CRP and JADAS 27-ESR, and occurrence of JADAS minimum disease activity and inactive disease at each visit.
Eligibility of tapering defined per protocol for corticosteroids
Eligibility of tapering defined per protocol for leflunomide
+14 more

Side effects data

From 2017 Phase 3 trial • 209 Patients • NCT02281552
12%
Nasopharyngitis
1%
Anaemia
1%
Interstitial lung disease
1%
Pneumocystis jirovecii pneumonia
1%
Pneumonia bacterial
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tofacitinib Immediate Release (IR)
Tofacitinib Modified Release (MR)

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 3
~39970

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,570 Previous Clinical Trials
10,910,203 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,475 Previous Clinical Trials
8,091,317 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

Frequently Asked Questions

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

Will this research project be studying people who are over the age of 50?

"Out of the total 419 clinical trials, this is one of the 63 that specifically looks at patients below 18 years old. To be eligible for enrollment in this trial, children must be between 2 to 18 years old."

Answered by AI

Do you know of any other research that has been conducted on Tofacitinib?

"At this time, there are a total of 7 Phase 3 trials and 34 clinical studies underway that are investigating tofacitinib. The majority of these medical investigations are based in Shanghai, but tofacitinib's clinical trials can be found at 656 locations worldwide."

Answered by AI

What are the main conditions that Tofacitinib has been shown to be effective for?

"Tofacitinib is a medication that has been used to treat juvenile arthritis. It can also be given to patients who are intolerant or unresponsive to methotrexate therapy."

Answered by AI

When was Tofacitinib cleared by the FDA?

"Tofacitinib has been given a safety score of 3. This is because it is currently in Phase 3 clinical trials, which suggests that while there is data supporting its efficacy, there are also multiple rounds of data confirming its safety."

Answered by AI

How many people with the condition being studied may join this clinical trial?

"In order to collect the desired data, this study requires 340 willing participants that meet the set inclusion criteria. Currently, there are two locations where patients can be enrolled: Johns Hopkins All Children's Hospital in Saint Pertersburg, Florida and Phoenix Children's Hospital in Phoenix, Arizona."

Answered by AI

Are there several facilities conducting this experiment in town?

"Johns Hopkins All Children's Hospital in Saint Petersburg, Florida, Phoenix Children's Hospital in Phoenix, Arizona and All Children's Hospital Speciality Physicians in Saint Petersburg are the main locations for this study. However, there are also 22 other sites where aspects of the trial are taking place."

Answered by AI
~19 spots leftby Mar 2025