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

Completed · Phase 2 · Has a placebo group

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT00976599

Run by

Pfizer

People needed

29

Starts

2009-11-01

Expected to finish

2011-07-01

Last updated by the study team

2013-01-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 .

Where it is running

• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — Birmingham, Alabama, United States
• Pfizer Investigational Site — La Jolla, California, United States
• Pfizer Investigational Site — Frederick, Maryland, United States
• Pfizer Investigational Site — Battle Creek, Michigan, United States
• Pfizer Investigational Site — Mayfield Village, Ohio, United States
• Pfizer Investigational Site — Mentor, Ohio, United States
• Pfizer Investigational Site — Willoughby, Ohio, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Dallas, Texas, United States
• Pfizer Investigational Site — Mesquite, Texas, United States
• Pfizer Investigational Site — Sunnyvale, Texas, United States
• Pfizer Investigational Site — Seattle, Washington, United States
• Pfizer Investigational Site — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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