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.

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

sites

Childrens Hospital Los Angeles

4650 Sunset Blvd
Los Angeles, California 90027

(323) 660-2450