Study Evaluating The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis
Status: | Completed |
---|---|
Conditions: | Arthritis, Rheumatoid Arthritis |
Therapuetic Areas: | Rheumatology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 7/16/2013 |
Start Date: | December 2009 |
End Date: | June 2013 |
Contact: | Pfizer CT.gov Call Center |
Phone: | 1-800-718-1021 |
Randomized, Parallel, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy And Safety Of SBI-087 In Seropositive Subjects With Active Rheumatoid Arthritis On A Stable Background Of Methotrexate
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.
Inclusion Criteria:
- 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)
Exclusion Criteria:
- Any significant health problem other than rheumatoid arthritis
- Any clinically significant laboratory abnormalities
- Any prior use of B cell-depleting therapy
We found this trial at
16
sites
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