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A Safety,Tolerability and Efficacy Study Of Tofacitinib In Pediatric Patients With Systemic Juvenile Idiopathic Arthritis

Last updated on May 27, 2019

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Study Location
Rady Children's Hospital San Diego- Education and Office Building
San Diego, California, 92123 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Arthritis Juvenile Idiopathic
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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- active sJIA disease according to ILAR criteria for at least 6 weeks before screening

- 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.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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- Previous JIA treatment with tofacitinib;

- Current symptoms or findings of myocarditis, endocarditis or more than minimal
pericardial effusion associated with sJIA. Current symptoms or findings of more than
minimal pleuritis with sJIA

- Subjects who have previously failed treatment with more than two biologic DMARDs.
Note: all subjects will be allowed to have previously failed one biologic DMARD, and
up to forty (40) percent of subjects will be allowed to have previously failed two
biologic DMARDs provided that washout periods are respected.

Trial Details
Administration
The form in which the study drug will be delivered to the patient's body.
Tablets
Liquid
Placebo
A placebo often looks like the investigational medication, but it has no active ingredient in it.
Yes addition
Duration
The time commitment for participation in the study.
Follow up: Up to 4 weeks
Screening: Up to 30 days
Treatment: Range 16 weeks
Site Visits
Follow up: Estimated 1 visits
Screening: At least 1 visits
Treatment: Range 8 visits
Prior Approval
The study drug has not been approved yet.
Post-Trial Access to Study Drug
Planned
Trial Procedures
Blood test
Physical examination
Urine test
Vital signs and measurements
Questionnaire
Keeping a diary
X-rays
NCT03000439
Pfizer
Recruiting
A Safety,Tolerability and Efficacy Study Of Tofacitinib In Pediatric Patients With Systemic Juvenile Idiopathic Arthritis

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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