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

Inclusion Criteria:

• Pediatric subjects with JIA aged from 2 to less than 18 years who met entry criteriafor the qualifying/index study and in the opinion of the investigator havesufficient evidence of JIA disease activity to warrant use of tofacitinib as aDMARD. Subjects turning 18 years of age during participation in the qualifying/indexstudy or subsequently will be eligible for participation in this study.

• The subject has discontinued disallowed concomitant medications for the requiredtime prior to the first dose of study drug, as defined in Appendix 1, and is takingonly those concomitant medications in doses and frequency allowed by the protocol.

• Fertile male subjects and female subjects of childbearing potential who are, in theopinion of the investigator, sexually active and at risk for pregnancy with theirpartner(s) must be using a highly effective method of contraception as outlined inthis protocol throughout the study and for at least 28 days after the last dose ofstudy medication.

• Subjects must have previously completed participation in a qualifying study oftofacitinib for the treatment of JIA. Subjects who have required earlierdiscontinuation of treatment in a qualifying study for reasons other thantofacitinib 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 orjudged to be opportunistic by the investigator within the 3 months prior to thefirst 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 singleepisode) herpes zoster or disseminated (a single episode) herpes simplex.