A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA
Status: | Recruiting |
---|---|
Conditions: | Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 2 - 17 |
Updated: | 3/24/2019 |
Start Date: | May 10, 2018 |
End Date: | July 18, 2023 |
Contact: | Pfizer CT.gov Call Center |
Email: | ClinicalTrials.gov_Inquiries@pfizer.com |
Phone: | 1-800-718-1021 |
EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF TOFACITINIB FOR TREATMENT OF SYSTEMIC JUVENILE IDIOPATHIC ARTHRITIS (SJIA) WITH ACTIVE SYSTEMIC FEATURES IN CHILDREN AND ADOLESCENT SUBJECTS
A randomized withdrawal study in which responders to open-label treatment with tofacitinib
will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the
double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects
will be discontinued once they experience sJIA flare. Once 31 flares are reported the study
will be completed.
will be randomized in a 1:1 ratio to tofacitinib or placebo in a double-blind phase. In the
double-blind phase "time to sJIA flare" will be evaluated as primary endpoint and subjects
will be discontinued once they experience sJIA flare. Once 31 flares are reported the study
will be completed.
Inclusion Criteria:
- 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:
- 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.
We found this trial at
15
sites
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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3333 Burnet Avenue # Mlc3008
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
1-513-636-4200
Cincinnati Children's Hospital Medical Center Patients and families from across the region and around the...
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Childrens Hospital Los Angeles Children's Hospital Los Angeles is a 501(c)(3) nonprofit hospital for pediatric...
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4401 Penn Avenue
Pittsburgh, Pennsylvania 15224
Pittsburgh, Pennsylvania 15224
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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3333 Burnet Avenue
Cincinnati, Ohio 45229
Cincinnati, Ohio 45229
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