A Study of Tocilizumab [RoActemra/Actemra] Versus Adalimumab in Patients With Rheumatoid Arthritis



Status:Archived
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:May 2010
End Date:September 2012

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A Multi-center, Randomized, Blinded, Parallel-group Study of the Reduction of Signs and Symptoms During Monotherapy Treatment With Tocilizumab 8 mg/kg Intravenously Versus Adalimumab 40 mg Subcutaneously in Patients With Rheumatoid Arthritis


This randomized, blinded, parallel arm study will evaluate the efficacy and safety of
tocilizumab [RoActemra/Actemra] versus adalimumab as monotherapy in patients with rheumatoid
arthritis who are intolerant of methotrexate or where continued treatment with methotrexate
is considered inappropriate. Patients will be randomized to receive either tocilizumab
(8mg/kg intravenously) every 4 weeks plus placebo sc every 2 weeks, or adalimumab (40mg
subcutaneously) every 2 weeks plus placebo iv every 4 weeks. Anticipated time on study
treatment is 24 weeks. With regard to the blind, the study nurse will be unblinded due to
the nature of the treatment administration, but the investigator and the patient will remain
blinded. Target sample size is 200-400 patients.



We found this trial at
21
sites
Austin, Texas
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Birmingham, Alabama
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Birmingham, AL
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Celebration, Florida
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Celebration, FL
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Centralia, Illinois
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Centralia, IL
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Charleston, South Carolina
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Charleston, SC
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Charlotte, North Carolina
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Charlotte, NC
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Chevy Chase, Maryland 20815
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Chevy Chase, MD
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Coeur D'Alene, Idaho
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Coeur D'Alene, ID
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Denver, Colorado
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Denver, CO
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Jackson, Mississippi
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Jackson, MS
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Lebanon, New Hampshire
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Lebanon, NH
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Lima, OH
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Little Rock, Arkansas
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Little Rock, AR
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Mountlake Terrace, Washington
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Mountlake Terrace, WA
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Nashville, Tennessee
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Nashville, TN
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Newington, Connecticut
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Newington, CT
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Omaha, Nebraska
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Omaha, NE
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Peoria, Arizona
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Peoria, AZ
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Philadelphia, Pennsylvania
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Philadelphia, PA
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Santa Clara, California 95051
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Santa Clara, CA
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West Orange, New Jersey
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West Orange, NJ
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