ABOUT THIS STUDY
- 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
- 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 .
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