Status:
COMPLETED
A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications
Lead Sponsor:
Pfizer
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheum...
Eligibility Criteria
Inclusion
- The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
- The patient has active disease as defined by both \>=4 tender or painful joints on motion and \>= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) \> 28 mm or a C-reactive protein (CRP) concentration \> 7 mg/dL.
- Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
- Patient must remain on at least one background traditional disease modifying antirheumatic drug.
- No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.
Exclusion
- Blood dyscrasias including confirmed: Hemoglobin \<9 g/dL or Hematocrit \<30%; White blood cell count \<3.0 x 109/L; Absolute neutrophil count \<1.2 x 109/L; Platelet count \<100 x 109/L.
- History of any other rheumatic autoimmune 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 :
May 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2011
Estimated Enrollment :
795 Patients enrolled
Trial Details
Trial ID
NCT00856544
Start Date
May 1 2009
End Date
January 1 2011
Last Update
January 10 2013
Active Locations (133)
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1
Pfizer Investigational Site
Huntsville, Alabama, United States, 35801
2
Pfizer Investigational Site
Jonesboro, Arkansas, United States, 72401
3
Pfizer Investigational Site
Palo Alto, California, United States, 94304
4
Pfizer Investigational Site
Stanford, California, United States, 94305