A Study To Evaluate The Effect Of CP-690,550 On Measures Of Kidney Function In Patients With Active Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | Any |
Updated: | 10/21/2012 |
Start Date: | April 2012 |
End Date: | November 2013 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
A Phase 1, Randomized, Placebo-Controlled, Two-Period, Fixed Sequence Study To Evaluate The Effect Of CP-690,550 On Measured Glomerular Filtration Rate In Patients With Active Rheumatoid Arthritis
The purpose of study is to explore the effect of CP-690,550 (Tofacitinib) on measures of
kidney function in patients with active rheumatoid arthritis (RA).
Inclusion Criteria:
- The patient must meet the American College of Rheumatology (ACR) classification
criteria for the diagnosis of rheumatoid arthritis by satisfying at least four of the
seven criteria.
- The patient must have active disease at both Screening and predose on Day 1 of Period
1.
- Patient must have had an inadequate response to at least one disease-modifying
antirheumatic drug (DMARD), non-biologic or biologic, due to ineffectiveness or
intolerance.
Exclusion Criteria:
- Pregnant or lactating women
- Serious medical conditions that would make treatment with CP-690,550 potentially
unsafe.
- A patient who has a history of asthma, multiple allergies or severe allergy (eg,
anaphylaxis) to any substance. In particular, a history of allergy to iodine,
povidone-iodine, iohexol or other iodinated contrast media.
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