A Study To Evaluate The Mechanism Of Action Of CP-690,550 In Patients With Rheumatoid Arthritis

Pfizer

Status and phase

Completed

Phase 2

Conditions

Rheumatoid Arthritis

Treatments

Drug: Placebo + Methotrexate

Drug: CP-690,550 + methotrexate

Study type

Interventional

Funder types

Industry

Identifiers

NCT00976599

A3921073

Details and patient eligibility

About

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.

Enrollment

29 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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 criteria

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 .