Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)

This is an open-label, non-randomized, multi-center, oral CP-690,550, multiple-dose (twice
daily for 5 days [except Day 5 when only morning dose will be given]) study in pediatric
subjects with JIA aged from 2 to less than 18 years. Baseline visit will occur within 1
month of the completion of the Screening Visit. The study will consist of three cohorts
based on the age of the subjects, Cohort 3: 2 to less than 6 years, Cohort 2: 6 to less than
12 years and Cohort 1: 12 to less than 18 years. In each cohort, at least 8 pediatric
subjects with JIA will participate in the study ensuring a total number of at least 24
pediatric evaluable subjects completing the PK period.

Inclusion Criteria:

1. Pediatric patients with JIA aged from 2 to less than 18 years with active JIA
(extended oligoarthritis, polyarthritis rheumatoid factor positive or negative,
psoriatic arthritis, enthesitis related arthritis), in 5 or more joints (using
American College Rheumatology definition of active joint) at the time of the first
study drug administration.

2. For subjects receiving MTX treatment, minimum duration of therapy is 4 months and
dose stable for at least 6 weeks prior to first dose of study drug. MTX may be
administered either orally or parenterally at doses not to exceed 20 mg/wk or 15
mg/m2/week.

3. A negative QuantiFERON-TB Gold In-Tube test performed within the 3 months prior to
screening. A negative PPD test can be substituted for the QuantiFERON-TB Gold In-Tube
test only if the central laboratory is unable to perform the test or cannot determine
the results to be positive or negative and the Pfizer medical monitor approves it, on
a case-by-case basis.

Exclusion Criteria:

1. Systemic JIA, persistent oligoarthritis, undifferentiated arthritis.

2. Current or recent history of uncontrolled clinically significant renal, hepatic,
hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological
disease.

3. History of any other rheumatic autoimmune disease.

4. Infections:

1. Latent or active TB or any history of previous TB.

2. Chronic infections.

3. 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.

4. Any treated infections within 2 weeks of Baseline visit.

5. A subject known to be infected with human immunodeficiency virus (HIV),
hepatitis B or hepatitis C virus.

6. History of infected joint prosthesis with prosthesis still in situ.

5. History of recurrent (more than one episode) herpes zoster or disseminated (a single
episode) herpes zoster or disseminated (a single episode) herpes simplex.

6. The biologic agents and DMARDs are disallowed at any time during this study. If a
subject needs to be treated with one of these agents, the subject should be
discontinued from the study.

7. Subjects who have been vaccinated with live or attenuated vaccines within the 6 weeks
prior to the first dose of study medication or is to be vaccinated with these
vaccines at any time during treatment or within 6 weeks following discontinuation of
study drug.

8. Subjects with a malignancy or with a history of malignancy with the exception of
adequately treated or excised non-metastatic basal cell or squamous cell cancer of
the skin or cervical carcinoma in situ.