Expired Study
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Zephyr Hills, Florida 33542


Purpose:

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 Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT00814307


Primary Contact:

Study Director
Pfizer CT.gov Call Center
Pfizer


Backup Contact:

N/A


Location Contact:

Zephyr Hills, Florida 33542
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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