A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis Currently on Methotrexate Therapy

Last updated: November 1, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Rheumatoid Arthritis

Arthritis And Arthritic Pain

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00106522
WA18062
  • Ages > 18
  • All Genders

Study Summary

This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo in combination with methotrexate (MTX) in patients with moderate to severe active rheumatoid arthritis (RA) currently on MTX therapy, and who have had an inadequate response to prior therapy with an anti-tumor necrosis factor (anti-TNF) agent. Patients will be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/kg or placebo iv, every 4 weeks. All patients will also receive methotrexate 10-25mg/week. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients at least 18 years of age with moderate to severe active RA for at least 6 months;

  • inadequate response to current anti-rheumatic therapies, including MTX;

  • inadequate response or intolerance to treatment with 1 or more anti-TNF therapieswithin 1 year of entering study;

  • on stable MTX for at least 8 weeks before entering study;

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

Exclusion

Exclusion Criteria:

  • major surgery (including joint surgery) within 8 weeks before screening, or plannedmajor surgery within 6 months after entering study;

  • women who are pregnant or breast-feeding.

Study Design

Total Participants: 499
Study Start date:
May 01, 2005
Estimated Completion Date:
November 30, 2007

Connect with a study center

  • Malvern, 3144
    Australia

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  • Shenton Park, 6008
    Australia

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  • Sydney, 2050
    Australia

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  • Woolloongabba, 4102
    Australia

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  • Aalst, 9300
    Belgium

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  • Hasselt, 3500
    Belgium

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  • Merksem, 2170
    Belgium

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  • Calgary, Alberta T2V 1P9
    Canada

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  • Edmonton, Alberta T5H 3V9
    Canada

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  • Winnipeg, Manitoba R3A 1M3
    Canada

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  • Burlington, Ontario L7M 4Y1
    Canada

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  • Kitchener, Ontario N2M 5N6
    Canada

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  • London, Ontario N6A 4V2
    Canada

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  • Mississauga, Ontario L5M 2V8
    Canada

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  • Newmarket, Ontario L3Y 3R7
    Canada

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  • Toronto, Ontario M5T 3L9
    Canada

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  • Montreal, Quebec H2L 1S6
    Canada

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    Sainte-foy, Quebec G1W 4R4
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  • Amiens, 80054
    France

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  • Bordeaux, 33076
    France

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  • Le Kremlin Bicetre, 94275
    France

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    Le Kremlin-bicetre, 94270
    France

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  • Lille, 59037
    France

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  • Lyon, 69437
    France

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  • Nice, 06202
    France

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  • Paris, 75475
    France

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  • Strasbourg, 67098
    France

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  • Toulouse, 31054
    France

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  • Berlin, 10117
    Germany

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  • Dresden, 01067
    Germany

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  • Gommern, 39245
    Germany

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  • Herne, 44652
    Germany

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    Köln, 50924
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  • Köln, 50924
    Germany

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    München, 81541
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  • München, 81541
    Germany

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    Vogelsang-gommern, 39245
    Germany

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  • Wiesbaden, 65191
    Germany

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  • Wuerzburg, 97080
    Germany

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    Würzburg, 97070
    Germany

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    Würzburg, 97070
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  • Reykjavik, 108
    Iceland

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  • Brescia, 25123
    Italy

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  • Milano, 20122
    Italy

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  • Padova, 35128
    Italy

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  • Pavia, 27100
    Italy

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  • Pisa, 56100
    Italy

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  • Udine, 33100
    Italy

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  • Guadalajara, 44620
    Mexico

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  • Enschede, 7511 JX
    Netherlands

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  • Nijmegen, 6525 GA
    Netherlands

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  • Ponce, 00716
    Puerto Rico

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  • Jonkoping, 551 85
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  • Karlstad, 65185
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  • Malmo, 205 02
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    Malmoe, 20502
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    Malmö, SE-20502
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  • Stockholm, 171 76
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  • Lausanne, 1011
    Switzerland

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  • Basingstoke, RG24 9NA
    United Kingdom

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  • Bath, BA1 1RL
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  • Birmingham, B29 6JD
    United Kingdom

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  • Cannock, WS11 5XY
    United Kingdom

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  • Derby, DE22 3NE
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  • Lancaster, LA1 4RP
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  • Leeds, LS1 3EX
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  • Liverpool, L9 7AL
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  • London, SE1 9RT
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  • Middlesborough, TS4 3BW
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  • Newcastle Upon Tyne, NE1 4LP
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  • Norwich, NR4 7UY
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  • Oxford, OX3 7LD
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  • Salford, M6 8HD
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  • Southampton, SO16 6YD
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  • Stoke-on-trent, ST6 7AG
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  • Birmingham, Alabama 35294
    United States

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  • Huntsville, Alabama 35801
    United States

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  • Scottsdale, Arizona 85251
    United States

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  • Tucson, Arizona 85724
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  • Hot Springs, Arkansas 71913
    United States

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  • Little Rock, Arkansas 72205
    United States

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  • Anaheim, California 92801
    United States

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  • Fullerton, California 92835
    United States

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  • Long Beach, California 90806
    United States

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  • Los Angeles, California 90095
    United States

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  • Palm Desert, California 92260
    United States

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  • San Diego, California 92108
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  • Santa Maria, California 93454
    United States

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  • Torrance, California 90505
    United States

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    Aurora, Colorado 80045
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  • Colorado Springs, Colorado 80910
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  • Aventura, Florida 33180
    United States

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  • Boca Raton, Florida 33486
    United States

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  • Fort Lauderdale, Florida 33334
    United States

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  • Palm Habor, Florida 34684
    United States

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    Palm Harbor, Florida 34684
    United States

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  • Sarasota, Florida 34239
    United States

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  • Tampa, Florida 33614
    United States

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  • Tavares, Florida 32778
    United States

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  • West Palm Beach, Florida 33407
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  • Zephyrhills, Florida 33540
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  • Atlanta, Georgia 30342
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  • Boise, Idaho 83702
    United States

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    Meridan, Idaho 83642
    United States

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  • Meridian, Idaho 83642
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  • Chicago, Illinois 60611
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  • Indianapolis, Indiana 46202-5100
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  • Bowling Green, Kentucky 42102
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  • Elizabethtown, Kentucky 42701
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  • Lexington, Kentucky 40515
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  • Louisville, Kentucky 40202
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  • New Orleans, Louisiana 70121
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  • Portland, Maine 04102
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  • Baltimore, Maryland 21201
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  • Wheaton, Maryland 20902
    United States

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  • Springfield, Massachusetts 01107
    United States

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  • Worcester, Massachusetts 01605
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  • Lansing, Michigan 48910
    United States

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  • Duluth, Minnesota 55805
    United States

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  • Rochester, Minnesota 55905
    United States

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  • Tupelo, Mississippi 38802
    United States

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  • Saint Louis, Missouri 63128
    United States

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  • St Louis, Missouri 63110
    United States

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  • Billings, Montana 59107-5100
    United States

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  • Missoula, Montana 59802
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  • Las Vegas, Nevada 89119
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  • Medford, New Jersey 08055
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  • Mercerville, New Jersey 08619
    United States

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  • Teaneck, New Jersey 07666
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  • Albany, New York 12206
    United States

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  • Binghamton, New York 13905
    United States

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  • Great Neck, New York 11020
    United States

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  • Johnson City, New York 13790
    United States

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    Lake Success, New York 11042
    United States

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  • New York, New York 10003
    United States

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  • Orchard Park, New York 14127
    United States

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  • Asheville, North Carolina 28801
    United States

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  • Chapel Hill, North Carolina 27599-7280
    United States

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  • Charlotte, North Carolina 28210
    United States

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  • Wilmington, North Carolina 28401
    United States

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  • Bismarck, North Dakota 58501
    United States

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  • Canton, Ohio 44718
    United States

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  • Cincinnati, Ohio 45219
    United States

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  • Oklahoma City, Oklahoma 73103
    United States

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  • Tulsa, Oklahoma 74104
    United States

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  • Eugene, Oregon 97401
    United States

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  • Bala Cynwyd, Pennsylvania 19004
    United States

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  • Danville, Pennsylvania 17822
    United States

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  • Duncansville, Pennsylvania 16635
    United States

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  • Philadelphia, Pennsylvania 19140
    United States

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  • Willow Grove, Pennsylvania 80045
    United States

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  • Hickory, South Carolina 28602
    United States

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  • Jackson, Tennessee 38305
    United States

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  • Austin, Texas 78705
    United States

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  • Dallas, Texas 75231
    United States

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  • Houston, Texas 77074
    United States

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  • Ogden, Utah 84403
    United States

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  • Norfolk, Virginia 23502
    United States

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  • Richmond, Virginia 23298
    United States

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  • Salem, Virginia 24153
    United States

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  • Seattle, Washington 98195
    United States

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  • Glendale, Wisconsin 53217
    United States

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