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

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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.


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
1919 East Thomas Road
Phoenix, Arizona 85016
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3333 Burnet Avenue # Mlc3008
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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4650 Sunset Blvd
Los Angeles, California 90027
 (323) 660-2450
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
412-692-5325
Children's Hospital of Pittsburgh of UPMC UPMC is one of the leading nonprofit health systems...
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3020 Childrens way
San Diego, California 92123
(858) 576-1700
Rady Children's Hospital - San Diego Rady Children's Hospital-San Diego is the region’s pediatric medical...
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Lake Success, New York 11042
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New Hyde Park, New York 11040
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1919 E Thomas Rd
Phoenix, Arizona 85006
(602) 933-1000
Phoenix Children's Hospital Phoenix Children's Hospital has provided hope, healing, and the best healthcare for...
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Portland, OR
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2612 Mendoza
Rosario, Santa Fe S2000PBJ
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Salt Lake City, Utah 84143
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San Diego, California 92123
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