A Study Of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis Who Have an Inadequate Response to or Are Unable to Tolerate Biologic and Non-Biologic DMARDs



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

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Open-Label Study to Evaluate the Safety, Tolerability and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis on Background Non-biologic DMARDs and Monotherapy Who Have an Inadequate Response to Current Non-Biologic or Biologic DMARDs


This 3 arm randomized open label study will evaluate the safety, tolerability and efficacy
of tocilizumab in patients with moderate to severe active rheumatoid arthritis, who have had
inadequate response to or are unable to tolerate DMARDs. Patients will be randomized to
receive tocilizumab either 4mg/kg iv or 8mg/kg iv with concomitant non-biologic DMARDs, or
8mg/kg iv without concomitant non-biologic DMARDs, every 4 weeks, for a total of 6
infusions. The anticipated time on study treatment is 3-12 months, and the target sample
size is 500-1000 individuals.



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44
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Medford, Oregon
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Albany, New York
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Albuquerque, New Mexico
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Albuquerque, NM
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Atlanta, Georgia
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Atlanta, GA
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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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Bismarck, North Dakota 58501
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Bismarck, ND
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Boston, Massachusetts
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Boston, MA
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Burlington, Vermont
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Burlington, VT
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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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Coeur D'Alene, Idaho
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Denver, Colorado
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Detroit, Michigan
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Detroit, MI
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Great Falls, Montana 59405
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Great Falls, MT
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Henderson, Nevada
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Jackson, Mississippi
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Jackson, MS
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Jeffersonville, Indiana
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Jeffersonville, IN
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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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Little Rock, Arkansas
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Little Rock, AR
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Louisville, Kentucky
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Louisville, KY
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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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Morgantown, West Virginia
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Morgantown, WV
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Mountlake Terrace, Washington
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Nashville, Tennessee
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Nashville, TN
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Newark, Delaware 19718
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Newark, DE
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Newington, Connecticut
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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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Ponca City, Oklahoma
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Ponca City, OK
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Richmond, Virginia
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Richmond, VA
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Santa Clara, California 95051
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Santa Clara, CA
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Sioux Falls, South Dakota
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Sioux Falls, SD
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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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