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

Last updated on February 21, 2019

FOR MORE INFORMATION
Study Location
Explorer Clinic, University of Minnesota Children's Hospital
Minneapolis, Minnesota, 55454 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Juvenile Idiopathic Arthritis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
2-17 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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.

NCT01513902
Pfizer
Completed
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)

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Pfizer Clinical Trials Contact Center

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[email protected]

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FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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