Long-Term Safety Study Of Tofacitinib In Patients With Juvenile Idiopathic Arthritis

Completed · Phase 2/Phase 3

Conditions studied: Juvenile Idiopathic Arthritis

In brief

Evaluate long-term safety and tolerability of tofacitinib in patients with JIA, who have previously participated in tofacitinib JIA studies.

Key facts

Study ID

NCT01500551

Run by

Pfizer

People needed

302

Starts

2013-03-18

Expected to finish

2025-02-12

Last updated by the study team

2026-03-23

Who can join

Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteria for the qualifying/index study and in the opinion of the investigator have sufficient evidence of JIA disease activity to warrant use of tofacitinib as a DMARD. Subjects turning 18 years of age during participation in the qualifying/index study or subsequently will be eligible for participation in this study.
• The subject has discontinued disallowed concomitant medications for the required time prior to the first dose of study drug, as defined in Appendix 1, and is taking only those concomitant medications in doses and frequency allowed by the protocol.
• Fertile male subjects and female subjects of childbearing potential who are, in the opinion of the investigator, sexually active and at risk for pregnancy with their partner(s) must be using a highly effective method of contraception as outlined in this protocol throughout the study and for at least 28 days after the last dose of study medication.
• Subjects must have previously completed participation in a qualifying study of tofacitinib for the treatment of JIA. Subjects who have required earlier discontinuation of treatment in a qualifying study for reasons other than tofacitinib related serious adverse events may be eligible.

You may not qualify if…

• persistent oligoarthritis, and undifferentiated JIA.
• Infections:
• Chronic infections.
• Any infection requiring hospitalization, parenteral antimicrobial therapy or judged to be opportunistic by the investigator within the 3 months prior to the first dose of study drug.
• Any treated infections within 2 weeks of baseline visit.
• A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
• History of infected joint prosthesis with prosthesis still in situ.
• History of recurrent (more than one episode) herpes zoster or disseminated (a single episode) herpes zoster or disseminated (a single episode) herpes simplex.

Where it is running

• Loma Linda University Children'S Hospital — Loma Linda, California, United States
• Loma Linda University Clinical Trials Center — Loma Linda, California, United States
• Loma Linda University Eye Institute — Loma Linda, California, United States
• Loma Linda University General Pediatric Clinic - Meridian — Loma Linda, California, United States
• Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology) — Loma Linda, California, United States
• Children's Hospital Los Angeles — Los Angeles, California, United States
• Pediatric Speciality Team Centers of LLU Children's Hospital (Rheumatology) — San Bernardino, California, United States
• Rady Children's Hospital Center for Pediatric Clinical Research — San Diego, California, United States
• Rady Children's Hospital Rheumatology Clinic — San Diego, California, United States
• Rady Children's Hospital San Diego- Education and Office Building — San Diego, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Rady Children's Research Pharmacy — San Diego, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• IDS Pharmacy — Washington D.C., District of Columbia, United States
• Nicklaus Children's Hospital — Miami, Florida, United States
• Center for Advanced Pediatrics — Atlanta, Georgia, United States
• AU Medical Center — Augusta, Georgia, United States
• Augusta University — Augusta, Georgia, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• Riley Hospital for Children at IU Health — Indianapolis, Indiana, United States
• Tufts Medical Center - Floating Hospital for Children — Boston, Massachusetts, United States
• Explorer Clinic, University of Minnesota Children's Hospital — Minneapolis, Minnesota, United States
• Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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