A Safety, Efficacy And Pharmacokinetics Study Of Tofacitinib In Pediatric Patients With sJIA

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis Juvenile Idiopathic

In brief

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. An interim analysis for efficacy and futility will be conducted when at least 20 flares have been observed. If either criterion is met, the study will be stopped. If neither criterion is met, the study will continue until the requisite number of flares are observed as determined by the number of flares included in the interim analysis and a statistical penalty for conducting the interim analysis.

Key facts

Study ID

NCT03000439

Run by

Pfizer

People needed

100

Starts

2018-05-10

Expected to finish

2024-03-27

Last updated by the study team

2025-06-03

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• active sJIA disease according to ILAR criteria before screening and at baseline (Day 1);
• 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.

You may not qualify if…

• Previous juvenile idiopathic arthritis (JIA) treatment with tofacitinib.
• Current symptoms or findings of myocarditis, endocarditis or more than minimal pericardial effusion associated with systemic juvenile idiopathic arthritis (sJIA). Current symptoms or findings of more than minimal pleuritis with sJIA.
• Current infection or serious infection within 3 months of study enrollment.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Ann & Robert H Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Cohen Children's Medical Center of New York — Lake Success, New York, United States
• Cohen Children's Medical Center of New York — New Hyde Park, New York, United States
• Instituto CAICI SRL — Rosario, Santa Fe Province, Argentina
• Centro Medico Privado de Reumatologia — San Miguel de Tucumán, Tucumán Province, Argentina
• Universitair Ziekenhuis Gent — Ghent, Belgium
• Faculdade de Medicina da UNESP — Botucatu, São Paulo, Brazil
• UPECLIN Unidade de Pesquisa Clinica da Faculdade de Medicina da UNESP — Botucatu, São Paulo, Brazil
• SPDM - Associacao Paulista para o Desenvolvimento da Medicina — São Paulo, Brazil
• SPDM - Associacao Paulista para o Desenvolvimento da Medicina — São Paulo, Brazil
• Instituto da Crianca do Hospital das Clinicas da FMUSP — São Paulo, Brazil
• Alberta Children's Hospital/University of Calgary — Calgary, Alberta, Canada
• Research Institute of McGill University Health Center, Glen site — Montreal, Quebec, Canada
• Children's Hospital of Chongqing Medical University — Chongqing, Chongqing Municipality, China
• Guangzhou Women and Children's Medical Center — Guangzhou, Guangdong, China
• Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology — Wuhan, Hubei, China
• The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
• Children's Hospital of Soochow University — Suzhou, Jiangsu, China
• Xi'an Children's Hospital — Xi'an, Shaanxi, China
• Chengdu Women's and Children's Central Hospital — Chengdu, Sichuan, China
• The Children's Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
• Beijing Children's Hospital, Capital Medical University/Rheumatology Department — Beijing, China
• Hospital Metropolitano — San José, Costa Rica
• Phoenix Children's Hospital — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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