Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis

Completed · Phase 2 · Has a placebo group

Conditions studied: Active Rheumatoid Arthritis

In brief

This study is designed to evaluate the safety and efficacy of a dose and dosage regimen of SBI-087 in seropositive patients with active Rheumatoid Arthritis, who are on a stable dose of methotrexate.

Key facts

Study ID

NCT01008852

Run by

Pfizer

People needed

210

Starts

2009-12-01

Expected to finish

2013-07-01

Last updated by the study team

2013-12-03

Who can join

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

You may qualify if…

• Meets the American College of Rheumatology (ACR) 1987 revised criteria for classification of Rheumatoid Arthritis (RA) for at least 6 months prior to screening
• Active RA as defined by >= 5 swollen and >= 5 tender joints (28-joint count) and at least 1 of the following: C-reactive protein >= 10 mg/L or Erythrocyte Sedimentation Rate >= 28 mm/h
• Must be seropositive as defined by a documented history of rheumatoid factor (RF) or anti-cyclic citrullinated peptide (anti-CCP) positivity
• Must be receiving a stable route and dose of methotrexate (up to 25 mg weekly)

You may not qualify if…

• Any significant health problem other than rheumatoid arthritis
• Any clinically significant laboratory abnormalities
• Any prior use of B cell-depleting therapy

Where it is running

• Pfizer Investigational Site — Palm Desert, California, United States
• Pfizer Investigational Site — Santa Monica, California, United States
• Pfizer Investigational Site — Westlake Village, California, United States
• Pfizer Investigational Site — Newark, Delaware, United States
• Pfizer Investigational Site — Miami, Florida, United States
• Pfizer Investigational Site — Palm Harbor, Florida, United States
• Pfizer Investigational Site — Springfield, Illinois, United States
• Pfizer Investigational Site — Worcester, Massachusetts, United States
• Pfizer Investigational Site — Grand Rapids, Michigan, United States
• Pfizer Investigational Site — Albuquerque, New Mexico, United States
• Pfizer Investigational Site — Syracuse, New York, United States
• Pfizer Investigational Site — Minot, North Dakota, United States
• Pfizer Investigational Site — Dayton, Ohio, United States
• Pfizer Investigational Site — Toledo, Ohio, United States
• Pfizer Investigational Site — Tulsa, Oklahoma, United States
• Pfizer Investigational Site — Charleston, South Carolina, United States
• Pfizer Investigational Site — Jackson, Tennessee, United States
• Pfizer Investigational Site — Spokane, Washington, United States
• Pfizer Investigational Site — Clarksburg, West Virginia, United States
• Pfizer Investigational Site — Buenos Aires, C.a.b.a., Argentina
• Pfizer Investigational Site — C.a.b.a, Argentina
• Pfizer Investigational Site — C.a.b.a, Argentina
• Pfizer Investigational Site — Winnipeg, Manitoba, Canada
• Pfizer Investigational Site — Toronto, Ontario, Canada
• Pfizer Investigational Site — Paradise Valley, Arizona, United States

Full record on ClinicalTrials.gov

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