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

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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
Albuquerque, New Mexico 87108
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Akron, Ohio 44314
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Akron, OH
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Anderson, South Carolina 29621
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Anderson, SC
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Atlantis, Florida 33462
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Atlantis, FL
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Beckley, West Virginia 25801
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Beckley, WV
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Bloomingdale, Illinois 60108
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Bloomingdale, IL
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Boston, Massachusetts 02115
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Boston, MA
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Bristol, Tennessee 37620
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Bristol, TN
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Detroit, Michigan 48202
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Detroit, MI
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Fargo, North Dakota 58104
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Fargo, ND
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Gilbert, Arizona 85234
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Gilbert, AZ
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Lewes, Delaware 19958
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Lewes, DE
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Los Angeles, California 90027
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Los Angeles, CA
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Norman, Oklahoma 73069
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Norman, OK
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Rochester, New York 14642
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Rochester, NY
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Seattle, Washington 98166
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Seattle, WA
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