A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis



Status:Completed
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:8/3/2016
Start Date:July 2005
End Date:December 2007

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Trial Summary
Trial Overview
Inclusion Criteria

A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus
methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized
to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate
7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is
3-12 months and the target sample size is 500+ individuals.


Inclusion Criteria:

- adult patients at least 18 years of age with active RA for at least 3 months;

- patients of reproductive potential must be using reliable methods of contraception.

Exclusion Criteria:

- major surgery (including joint surgery) within 8 weeks before entering study or
planned major surgery within 6 months after entering study;

- treatment with methotrexate (MTX) within 6 months of entering study;

- patients who have stopped previous MTX treatment due to toxicity or lack of response;

- women who are pregnant or breast-feeding.
We found this trial at
67
sites
Clinical Trial Facility in Bowling Green Kentucky
Bowling Green, Kentucky 42101
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Bowling Green, KY
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Clinical Trial Facility in Albany New York
Albany, New York 12205
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Albany, NY
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Clinical Trial Facility in Amarillo Texas
Amarillo, Texas
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Amarillo, TX
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Clinical Trial Facility in Austin Texas
Austin, Texas 78744
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Austin, TX
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Clinical Trial Facility in Baton Rouge Louisiana
Baton Rouge, Louisiana 70809
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Baton Rouge, LA
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Clinical Trial Facility in Buenos Aires
Buenos Aires,
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Buenos Aires,
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Clinical Trial Facility in Canton Ohio
Canton, Ohio 44718
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Canton, OH
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Clinical Trial Facility in Cedar Rapids Iowa
Cedar Rapids, Iowa 52402
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Cedar Rapids, IA
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Clinical Trial Facility in Charleston South Carolina
Charleston, South Carolina 29412
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Charleston, SC
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Clinical Trial Facility in Chesapeake Virginia
Chesapeake, Virginia 23320
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Chesapeake, VA
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Clinical Trial Facility in Columbia South Carolina
Columbia, South Carolina
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Columbia, SC
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Clinical Trial Facility in Des Moines Iowa
Des Moines, Iowa
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Des Moines, IA
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Clinical Trial Facility in Dover New Hampshire
Dover, New Hampshire 03820
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Dover, NH
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Clinical Trial Facility in Duncansville Pennsylvania
Duncansville, Pennsylvania 16635
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Duncansville, PA
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Clinical Trial Facility in Eagan Minnesota
Eagan, Minnesota 55122
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Eagan, MN
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Clinical Trial Facility in Fayetteville North Carolina
Fayetteville, North Carolina 28304
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Fayetteville, NC
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Clinical Trial Facility in Flowood Mississippi
Flowood, Mississippi 39232
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Flowood, MS
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Clinical Trial Facility in Grand Rapids Michigan
Grand Rapids, Michigan 49503
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Grand Rapids, MI
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Clinical Trial Facility in Greenbelt Maryland
Greenbelt, Maryland 20770
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Greenbelt, MD
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Clinical Trial Facility in Greenville South Carolina
Greenville, South Carolina 29605
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Greenville, SC
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Clinical Trial Facility in Haddon Heights New Jersey
Haddon Heights, New Jersey 08035
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Haddon Heights, NJ
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Clinical Trial Facility in Hickory South Carolina
Hickory, South Carolina 28602
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Hickory, SC
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Clinical Trial Facility in Hixson Tennessee
Hixson, Tennessee 37343
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Hixson, TN
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Clinical Trial Facility in Huntington Beach California
Huntington Beach, California 92646
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Huntington Beach, CA
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Clinical Trial Facility in Idaho Falls Idaho
Idaho Falls, Idaho
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Idaho Falls, ID
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Clinical Trial Facility in Indianapolis Indiana
Indianapolis, Indiana 46202
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Indianapolis, IN
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Clinical Trial Facility in Jupiter Florida
Jupiter, Florida 33458
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Jupiter, FL
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Clinical Trial Facility in Kalamazoo Michigan
Kalamazoo, Michigan 49048
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Kalamazoo, MI
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Clinical Trial Facility in Lansing Michigan
Lansing, Michigan 48912
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Lansing, MI
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Clinical Trial Facility in Little Rock Arkansas
Little Rock, Arkansas
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Little Rock, AR
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Clinical Trial Facility in Long Beach California
Long Beach, California 90806
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Long Beach, CA
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Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Los Angeles, CA
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Clinical Trial Facility in Mayfield Ohio
Mayfield, Ohio 44143
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Mayfield, OH
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Clinical Trial Facility in Meridian Idaho
Meridian, Idaho
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Meridian, ID
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Clinical Trial Facility in Mesa Arizona
Mesa, Arizona
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Mesa, AZ
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Clinical Trial Facility in Mesquite Texas
Mesquite, Texas 75150
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Mesquite, TX
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Clinical Trial Facility in Montgomery Alabama
Montgomery, Alabama 36106
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Montgomery, AL
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Clinical Trial Facility in Morton Grove Illinois
Morton Grove, Illinois 60053
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Morton Grove, IL
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Clinical Trial Facility in Mountlake Terrace Washington
Mountlake Terrace, Washington
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Mountlake Terrace, WA
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Clinical Trial Facility in Nashua New Hampshire
Nashua, New Hampshire 03060
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Nashua, NH
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Clinical Trial Facility in Nashville Tennessee
Nashville, Tennessee 37232
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Nashville, TN
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Clinical Trial Facility in New Brunswick New Jersey
New Brunswick, New Jersey 08901
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New Brunswick, NJ
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Clinical Trial Facility in Oklahoma City Oklahoma
Oklahoma City, Oklahoma
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Oklahoma City, OK
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Clinical Trial Facility in Olympia Washington
Olympia, Washington 98502
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Olympia, WA
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Clinical Trial Facility in Palm Habor Florida
Palm Habor, Florida 34684
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Palm Habor, FL
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Clinical Trial Facility in Palm Harbor Florida
Palm Harbor, Florida 34684
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Palm Harbor, FL
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Clinical Trial Facility in Palm Springs California
Palm Springs, California 92262
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Palm Springs, CA
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Clinical Trial Facility in Paradise Valley Arizona
Paradise Valley, Arizona 85253
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Paradise Valley, AZ
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Philadelphia, PA
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Clinical Trial Facility in Phoenix Arizona
Phoenix, Arizona
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Phoenix, AZ
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Clinical Trial Facility in Pittsfield Massachusetts
Pittsfield, Massachusetts 01201
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Pittsfield, MA
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Clinical Trial Facility in Port Orange Florida
Port Orange, Florida
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Port Orange, FL
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Clinical Trial Facility in Sacramento California
Sacramento, California 95825
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Sacramento, CA
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Clinical Trial Facility in Saint Louis Missouri
Saint Louis, Missouri 63110
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Saint Louis, MO
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Clinical Trial Facility in San Leandro California
San Leandro, California
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San Leandro, CA
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Clinical Trial Facility in Santa Maria California
Santa Maria, California 93454
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Santa Maria, CA
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Clinical Trial Facility in Slidell Louisiana
Slidell, Louisiana 70458
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Slidell, LA
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Clinical Trial Facility in Spokane Washington
Spokane, Washington
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Spokane, WA
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Clinical Trial Facility in Springfield Illinois
Springfield, Illinois 62704
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Springfield, IL
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Clinical Trial Facility in St Cloud Minnesota
St Cloud, Minnesota 56301
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St Cloud, MN
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Clinical Trial Facility in Syracuse New York
Syracuse, New York 13202
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Syracuse, NY
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Clinical Trial Facility in Tampa Florida
Tampa, Florida
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Tampa, FL
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Clinical Trial Facility in Tulsa Oklahoma
Tulsa, Oklahoma 74136
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Tulsa, OK
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Clinical Trial Facility in Tupelo Mississippi
Tupelo, Mississippi 38801
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Tupelo, MS
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Clinical Trial Facility in Willow Grove Pennsylvania
Willow Grove, Pennsylvania 19090
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Willow Grove, PA
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Clinical Trial Facility in Wyomissing Pennsylvania
Wyomissing, Pennsylvania 19610
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Wyomissing, PA
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Clinical Trial Facility in Yakima Washington
Yakima, Washington 98902
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Yakima, WA
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