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

CompletedPhase 2, Phase 3

Sponsor: Pfizer

Conditions: Juvenile Idiopathic Arthritis

Interventions: Tofacitinib, Tofacitinib

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Germany

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

Eligibility overview

Sex: ALL

Age: 2 Years to 18 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* persistent oligoarthritis, and undifferentiated JIA.
* Infections:

1. Chronic infections.
2. 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.
3. Any treated infections within 2 weeks of baseline visit.
4. A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
5. 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.

Locations (104)

Little Rock, Arkansas, United States
Loma Linda, California, United States
Loma Linda, California, United States
Loma Linda, California, United States
Loma Linda, California, United States
Loma Linda, California, United States
Los Angeles, California, United States
San Bernardino, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
San Diego, California, United States
Hartford, Connecticut, United States
Washington D.C., District of Columbia, United States
Washington D.C., District of Columbia, United States
Miami, Florida, United States
Atlanta, Georgia, United States
Augusta, Georgia, United States
Augusta, Georgia, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Hackensack, New Jersey, United States
Lake Success, New York, United States
New York, New York, United States
The Bronx, New York, United States
Charlotte, North Carolina, United States
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