Status:
COMPLETED
A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To explore the effect of CP-690,550 on blood and synovial markers in subjects with rheumatoid arthritis. To evaluate the safety, tolerability and efficacy of CP-690,550.
Eligibility Criteria
Inclusion
- Subject must have a diagnosis of rheumatoid arthritis based on the American College of Rheumatology Association
- The subject has active disease at both Screening and Baseline, as defined:
- ≥4 joints tender or painful on motion, AND
- ≥4 joints swollen;
- The subject must have at least one knee, one elbow, one wrist or two metacarpophalangeal joints with active synovitis suitable for biopsy by the shaver technique
Exclusion
- No arthroscopy should have been performed in the past 3 months in the same joint that is to be biopsied in this study.
- No intra-articular steroids should have been injected in the joint to be biopsied in this study in the previous 3 months.
- Subjects with evidence of hematopoietic disorders or evidence of hemoglobin levels \< 9.0 gm/dL or hematocrit \< 30 % at screening visit or within the 3 months prior to baseline synovial biopsy.
- An absolute white blood cell (WBC) count of \< 3.0 x 109/L (\<3000/mm3) or absolute neutrophil count of \<1.2 X 109/L (\<1200/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
- Thrombocytopenia, as defined by a platelet count \<100 x 109/L (\< 100,000/mm3) at screening visit or within the 3 months prior to baseline synovial biopsy.
- Estimated GFR less than 40 ml/min based on Cockcroft Gault calculation .
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT00976599
Start Date
November 1 2009
End Date
July 1 2011
Last Update
January 9 2013
Active Locations (15)
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1
Pfizer Investigational Site
Birmingham, Alabama, United States, 35205
2
Pfizer Investigational Site
Birmingham, Alabama, United States, 35209
3
Pfizer Investigational Site
Birmingham, Alabama, United States, 35216
4
Pfizer Investigational Site
La Jolla, California, United States, 92037