A Study Comparing 2 Doses Of CP-690,550 Vs. Placebo For The Treatment Of Rheumatoid Arthritis In Patients On Other Background Arthritis Medications

Completed · Phase 3 · Has a placebo group

Conditions studied: Arthritis, Rheumatoid

In brief

This Phase 3 study is intended to provide evidence that CP-690,550 dosed 5 mg BID and 10 mg BID is safe and effective when used in combination with a variety of traditional disease modifying antirheumatic drugs in adult patients with 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

NCT00856544

Run by

Pfizer

People needed

795

Starts

2009-05-01

Expected to finish

2011-01-01

Last updated by the study team

2013-01-10

Who can join

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

You may qualify if…

• The patient has a diagnosis of Rheumatoid Arthritis based on the American College of Rheumatology (ACR) 1987 Revised Criteria.
• The patient has active disease as defined by both >=4 tender or painful joints on motion and >= 4 joints swollen; and either an erythrocyte sedimentation rate (ESR) > 28 mm or a C-reactive protein (CRP) concentration > 7 mg/dL.
• Patient had an inadequate response to at least one disease modifying antirheumatic drug (traditional or biologic) due to lack of efficacy or toxicity.
• Patient must remain on at least one background traditional disease modifying antirheumatic drug.
• No evidence of inadequately treated latent or active infection with Mycobacterium tuberculosis.

You may not qualify if…

• Blood dyscrasias including confirmed: Hemoglobin <9 g/dL or Hematocrit <30%; White blood cell count <3.0 x 109/L; Absolute neutrophil count <1.2 x 109/L; Platelet count <100 x 109/L.
• History of any other rheumatic autoimmune 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 — Jonesboro, Arkansas, United States
• Pfizer Investigational Site — Palo Alto, California, United States
• Pfizer Investigational Site — Stanford, California, United States
• Pfizer Investigational Site — Boulder, Colorado, United States
• Pfizer Investigational Site — Denver, Colorado, United States
• Pfizer Investigational Site — Danbury, Connecticut, United States
• Pfizer Investigational Site — Hamden, Connecticut, United States
• Pfizer Investigational Site — Trumbull, Connecticut, United States
• Pfizer Investigational Site — New Port Richey, Florida, United States
• Pfizer Investigational Site — Ocala, Florida, United States
• Pfizer Investigational Site — Plantation, Florida, United States
• Pfizer Investigational Site — Port Richey, Florida, United States
• Pfizer Investigational Site — Tamarac, Florida, United States
• Pfizer Investigational Site — Tampa, Florida, United States
• Pfizer Investigational Site — Decatur, Georgia, United States
• Pfizer Investigational Site — Marietta, Georgia, United States
• Pfizer Investigational Site — Maywood, Illinois, United States
• Pfizer Investigational Site — Oakbrook Terrace, Illinois, United States
• Pfizer Investigational Site — Rockford, Illinois, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Vernon Hills, Illinois, United States
• Pfizer Investigational Site — Evansville, Indiana, United States
• Pfizer Investigational Site — Indianapolis, Indiana, United States
• Pfizer Investigational Site — Huntsville, Alabama, United States

Full record on ClinicalTrials.gov

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