A Study of Tocilizumab as Monotherapy and in Combination With Methotrexate Versus Methotrexate in Patients With Early Moderate to Severe Rheumatoid Arthritis



Status:Archived
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:October 2009
End Date:May 2014

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Multi-center, Randomized, Double-blind, Parallel Group Study of the Safety, Disease Remission & Prevention of Structural Joint Damage During Treatment With Tocilizumab as a Monotherapy & in Combination With Methotrexate Versus Methotrexate in Pts With Early Moderate to Severe Rheumatoid Arthritis


This randomized, double-blind, parallel group study will assess the safety, disease
remission and prevention of structural joint damage on treatment with tocilizumab as
monotherapy or in combination with methotrexate, versus methotrexate in patients with early
moderate to severe rheumatoid arthritis. Patients will be randomized to receive either A)
tocilizumab (8mg/kg iv every 4 weeks) plus placebo, or B) tocilizumab (8mg/kg iv every 4
weeks) plus methotrexate (7.5-20mg po weekly), or C) tocilizumab (4mg/kg iv every 4 weeks)
plus methotrexate (7.5-20mg po weekly), or D) placebo plus methotrexate (7.5-20mg po
weekly). Patients in groups C and D who have not achieved low disease activity at week 52
can receive tocilizumab 8mg/kg iv every 4 weeks. Anticipated time on study treatment is 104
weeks and target sample size is >1'000 individuals



We found this trial at
28
sites
Philadelphia, Pennsylvania
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Philadelphia, PA
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Albany, New York
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Albany, NY
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Albuquerque, New Mexico
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Albuquerque, NM
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Austin, Texas
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Austin, TX
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Bettendorf, Iowa 52722
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Bettendorf, IA
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1351 Kimberly Rd
Bettendorf, Iowa 52722
(563) 355-7733
Hematology Oncology Associates of the Quad Cities
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Bettendorf, IA
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Birmingham, Alabama
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Birmingham, AL
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Boston, Massachusetts
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Boston, MA
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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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Denver, Colorado
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Denver, CO
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Detroit, Michigan
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Detroit, MI
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Jackson, Mississippi
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Jackson, MS
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Kansas City, Kansas
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Kansas City, KS
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Lebanon, New Hampshire
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Lebanon, NH
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Lima, OH
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Metairie, Louisiana
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Metairie, LA
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Milwaukee, Wisconsin
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Milwaukee, WI
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Mountlake Terrace, Washington
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Mountlake Terrace, WA
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Newington, Connecticut
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Newington, CT
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Peoria, Arizona
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Peoria, AZ
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Ponca City, Oklahoma
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Ponca City, OK
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Santa Clara, California 95051
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Santa Clara, CA
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St Louis, Missouri
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St Louis, MO
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West Orange, New Jersey
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West Orange, NJ
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