Status:
COMPLETED
A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Ar...
Eligibility Criteria
Inclusion
- The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) \>28 mm in the local laboratory. 2. CRP \>7 mg/L in the central laboratory
- Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
- No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
- Patient has washed out of all DMARDs other that antimalarials
Exclusion
- Blood dyscrasias including confirmed: 1. Hemoglobin \<9 g/dL or Hematocrit \<30%; 2. White blood cell count \<3.0 x 109/L; 3. Absolute neutrophil count \<1.2 x 109/L; 4. Platelet count \<100 x 109/L
- History of any other autoimmune rheumatic disease other than Sjogren's syndrome
- No malignancy or history of malignancy.
- History of infection requiring hospitalization, parenteral antimicrobial therapy, or as otherwise judged clinically significant by the investigator, within the 6 months prior to the first dose of study drug
Key Trial Info
Start Date :
February 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
611 Patients enrolled
Trial Details
Trial ID
NCT00814307
Start Date
February 1 2009
End Date
June 1 2010
Last Update
January 18 2013
Active Locations (95)
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1
Pfizer Investigational Site
Gilbert, Arizona, United States, 85234
2
Pfizer Investigational Site
Tucson, Arizona, United States, 85704
3
Pfizer Investigational Site
Hot Springs, Arkansas, United States, 71913
4
Pfizer Investigational Site
Jacksonville, Florida, United States, 32216