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

This is a Phase 2/3, long term, open‑label, follow‑up study. Subjects will have previously
participated in qualifying/index JIA studies of tofacitinib. Those who have already completed
such participation and enroll outside the 14 day window following completion of the End of
Study (EOS) Visit of the qualifying/index study will participate in a screening Visit to
determine eligibility. A Baseline Visit will then occur within 28 days after the Screening
Visit. For subjects who are completing participation in a qualifying study of tofacitinib and
enrolling on the same day of the EOS Visit of the qualifying/index study, the EOS Visit of
the qualifying/index study can be combined with the Screening and Baseline Visits for this
study. The subjects who enroll within the 14 day window following completion of the EOS Visit
of the qualifying/index study will participate in a combined Screening and Baseline Visit for
this study. After the Baseline Visit, visits will occur at 1 month (1 month=30 days) and 3
months, then every 3 months thereafter as long as the subject remains in the study.

Approximately 340 participants are projected to enroll into this open label extension study
after completing a qualifying/index study in the JIA program.

This study (A3921145) is planned to run until the first global marketing approval of
tofacitinib for the treatment of JIA. The total duration of an individual subject's
participation may vary depending upon when they enter the trial.

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:

- Systemic JIA (sJIA) with active systemic features other than active joints and
elevated acute phase reactants, 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 6 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.