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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 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Side effects data
From 2017 Phase 3 trial • 209 Patients • NCT0228155210%
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
4,635 Previous Clinical Trials
17,736,409 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,525 Previous Clinical Trials
14,908,972 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a long-term infection.I am under 18, have JIA, and need tofacitinib as per my doctor's advice.I am infected with HIV, hepatitis B, or hepatitis C.You have had an infected joint replacement in the past and still have the replacement in place.I have stopped taking certain medications as required and only take approved ones.I have long-lasting arthritis in few joints and a type of juvenile arthritis.You had an infection that required treatment within the two weeks leading up to the start of the study.I haven't had a serious infection or been hospitalized for an infection in the last 3 months.I have had shingles more than once or a widespread herpes simplex infection.I have completed a study for JIA treatment with tofacitinib, without stopping early due to serious side effects.
Research Study Groups:
This trial has the following groups:- Group 1: Tofacitinib
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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