A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

This Phase 3 study is intended to provide evidence of the efficacy and safety of CP 690,550 when dosed 5 mg and 10 mg twice a day as monotherapy in adult patients with moderate to severe Rheumatoid Arthritis. It is intended to confirm the benefits of CP-690,550 in improving signs and symptoms and physical function that were observed in the Phase 2 Rheumatoid Arthritis studies.

Key facts

Study ID

NCT00814307

Run by

Pfizer

People needed

611

Starts

2009-02-01

Expected to finish

2010-06-01

Last updated by the study team

2013-01-18

Who can join

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

You may qualify if…

• The patient has a diagnosis of RA based upon the American College of Rheumatology (ACR) 1987 Revised Criteria.
• The patient has active disease at both Screening and Baseline, as defined by both: ≥6 joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local laboratory. 2. CRP >7 mg/L in the central laboratory
• Patient had an inadequate response to at least one DMARD (traditional or biologic) due to lack of efficacy or toxicity.
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
• Patient has washed out of all DMARDs other that antimalarials

You may not qualify if…

• Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
• History of any other autoimmune rheumatic 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

Where it is running

• Pfizer Investigational Site — Tucson, Arizona, United States
• Pfizer Investigational Site — Hot Springs, Arkansas, United States
• Pfizer Investigational Site — Jacksonville, Florida, United States
• Pfizer Investigational Site — Sarasota, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Venice, Florida, United States
• Pfizer Investigational Site — Zephyrhills, Florida, United States
• Pfizer Investigational Site — Rockford, Illinois, United States
• Pfizer Investigational Site — Frederick, Maryland, United States
• Pfizer Investigational Site — Hyannis, Massachusetts, United States
• Pfizer Investigational Site — Kalamazoo, Michigan, United States
• Pfizer Investigational Site — Teaneck, New Jersey, United States
• Pfizer Investigational Site — Albany, New York, United States
• Pfizer Investigational Site — Olean, New York, United States
• Pfizer Investigational Site — Rochester, New York, United States
• Pfizer Investigational Site — Charlotte, North Carolina, United States
• Pfizer Investigational Site — Rocky Mount, North Carolina, United States
• Pfizer Investigational Site — Winston-Salem, North Carolina, United States
• Pfizer Investigational Site — Minot, North Dakota, United States
• Pfizer Investigational Site — Dayton, Ohio, United States
• Pfizer Investigational Site — Bethlehem, Pennsylvania, United States
• Pfizer Investigational Site — Duncansville, Pennsylvania, United States
• Pfizer Investigational Site — West Reading, Pennsylvania, United States
• Pfizer Investigational Site — Greenville, South Carolina, United States
• Pfizer Investigational Site — Gilbert, Arizona, United States

Full record on ClinicalTrials.gov

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