Status:
COMPLETED
Pharmacokinetics Of CP-690,550 In Pediatric Patients With Juvenile Idiopathic Arthritis (JIA)
Lead Sponsor:
Pfizer
Conditions:
Juvenile Idiopathic Arthritis
Eligibility:
All Genders
2-17 years
Phase:
PHASE1
Brief Summary
Phase 1 study to describe pharmacokinetics of CP-690,550 in pediatric patients 2 to less than 18 years of age with Juvenile Idiopathic Rheumatoid Arthritis (JIA).
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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.
- 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.
- 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
- Systemic JIA, persistent oligoarthritis, undifferentiated arthritis.
- Current or recent history of uncontrolled clinically significant renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, or neurological disease.
- History of any other rheumatic autoimmune disease.
- Infections:
- Latent or active TB or any history of previous TB.
- Chronic infections.
- 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.
- Any treated infections within 2 weeks of Baseline visit.
- A subject known to be infected with human immunodeficiency virus (HIV), hepatitis B or hepatitis C virus.
- 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.
- 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.
- 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.
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2015
Estimated Enrollment :
26 Patients enrolled
Trial Details
Trial ID
NCT01513902
Start Date
March 1 2013
End Date
December 1 2015
Last Update
July 4 2016
Active Locations (10)
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1
Explorer Clinic, University of Minnesota Children's Hospital
Minneapolis, Minnesota, United States, 55454
2
Clinical and Translational Science Institute Masonic Clinical Research Unit (Administration Only)
Minneapolis, Minnesota, United States, 55455
3
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
4
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, United States, 97227