A Study of Tocilizumab and Methotrexate Treatment Strategies (Adding Tocilizumab to Methotrexate Versus Switching to Tocilizumab) in Patients With Active Rheumatoid Arthritis With Inadequate Response to Prior Methotrexate Treatment

Last updated: July 16, 2014
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Dermatomyositis (Connective Tissue Disease)

Arthritis And Arthritic Pain

Rheumatoid Arthritis

Treatment

N/A

Clinical Study ID

NCT00810199
MA21488
2008-001847-20
  • Ages > 18
  • All Genders

Study Summary

This 2 arm study will compare 2 treatment strategies based on tocilizumab in combination with methotrexate or placebo in patients with moderate to severe rheumatoid arthritis. Patients receiving methotrexate treatment will be randomized to receive either a) tocilizumab 8 mg intravenous (iv) every 4 weeks + methotrexate orally (po) weekly or b) tocilizumab 8 mg iv every 4 weeks + placebo po weekly. After the first 24 weeks of blinded treatment, treatment adjustments (increase or decrease of treatment intensity) may be introduced at intervals, based on response. The anticipated time on study treatment is up to 3 years, and the target sample size is approximately 470 patients.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients, ≥ 18 years of age;

  • moderate to severe active rheumatoid arthritis (Disease Activity Score (DAS28) > 4.4);

  • inadequate response to methotrexate;

  • on a stable dose of ≥ 15mg/week methotrexate for at least 6 weeks.

Exclusion

Exclusion Criteria:

  • prior treatment with a biologic;

  • Rheumatoid arthritis (RA) functional class IV;

  • known active current or history of recurrent bacterial, viral, fungal, mycobacterialor other infections;

  • evidence of active malignant disease.

Study Design

Total Participants: 556
Study Start date:
March 01, 2009
Estimated Completion Date:
January 31, 2013

Connect with a study center

  • Belo Horizonte, MG 30130-100
    Brazil

    Site Not Available

  • Porto Alegre, RS 90035-903
    Brazil

    Site Not Available

  • Sao Paulo, SP 04026-000
    Brazil

    Site Not Available

  • empty

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • empty

    São Paulo, 05403-000
    Brazil

    Site Not Available

  • Rijeka, 51000
    Croatia

    Site Not Available

  • Zagreb, 10000
    Croatia

    Site Not Available

  • Frederiksberg, 2000
    Denmark

    Site Not Available

  • Hellerup, 2900
    Denmark

    Site Not Available

  • empty

    Køge, 4600
    Denmark

    Site Not Available

  • Køge, 4600
    Denmark

    Site Not Available

  • Tallinn, 13419
    Estonia

    Site Not Available

  • Abbeville, 80142
    France

    Site Not Available

  • Boulogne-billancourt, 92104
    France

    Site Not Available

  • Brest, 29609
    France

    Site Not Available

  • Echirolles, 38434
    France

    Site Not Available

  • Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • empty

    Le Kremlin-bicetre, 94270
    France

    Site Not Available

  • Le Mans, 72037
    France

    Site Not Available

  • Marseille, 13285
    France

    Site Not Available

  • Monaco, 98012
    France

    Site Not Available

  • Nantes, 44035
    France

    Site Not Available

  • Nice, 06202
    France

    Site Not Available

  • Paris, 75571
    France

    Site Not Available

  • Pierre Benite, 69495
    France

    Site Not Available

  • Vandoeuvre-les-nancy, 54511
    France

    Site Not Available

  • Aachen, 52064
    Germany

    Site Not Available

  • Berlin, 13125
    Germany

    Site Not Available

  • Dresden, 01307
    Germany

    Site Not Available

  • Erlangen, 91054
    Germany

    Site Not Available

  • Hamburg, 22081
    Germany

    Site Not Available

  • Jena, 07747
    Germany

    Site Not Available

  • empty

    Koeln, 50924
    Germany

    Site Not Available

  • empty

    Köln, 50924
    Germany

    Site Not Available

  • Köln, 50924
    Germany

    Site Not Available

  • Muenchen, 80336
    Germany

    Site Not Available

  • empty

    München, 80336
    Germany

    Site Not Available

  • empty

    München, 80336
    Germany

    Site Not Available

  • Ratingen, 40882
    Germany

    Site Not Available

  • Wuerzburg, 97080
    Germany

    Site Not Available

  • empty

    Würzburg, 97080
    Germany

    Site Not Available

  • empty

    Würzburg, 97070
    Germany

    Site Not Available

  • Athens, 11527
    Greece

    Site Not Available

  • Thessaloniki, 54642
    Greece

    Site Not Available

  • Afula, 18101
    Israel

    Site Not Available

  • Beer Sheva, 8410101
    Israel

    Site Not Available

  • Haifa, 34354
    Israel

    Site Not Available

  • Kfar Saba, 44281
    Israel

    Site Not Available

  • Ramat-Gan, 52621
    Israel

    Site Not Available

  • Rishon Lezion,
    Israel

    Site Not Available

  • Tel Aviv, 6423906
    Israel

    Site Not Available

  • Ancona, 60020
    Italy

    Site Not Available

  • Bari, 70124
    Italy

    Site Not Available

  • Perugia, 06122
    Italy

    Site Not Available

  • Prato, 59100
    Italy

    Site Not Available

  • Roma, 00168
    Italy

    Site Not Available

  • Bauska, 3901
    Latvia

    Site Not Available

  • Daugavpils, 5417
    Latvia

    Site Not Available

  • Liepaja, 3400
    Latvia

    Site Not Available

  • Riga, 1006
    Latvia

    Site Not Available

  • Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Leiden, 2333 ZA
    Netherlands

    Site Not Available

  • Maastricht, 6202 AZ
    Netherlands

    Site Not Available

  • Nijmegen, 6525 GA
    Netherlands

    Site Not Available

  • Utrecht, 3584 CX
    Netherlands

    Site Not Available

  • Drammen, 3004
    Norway

    Site Not Available

  • Gjettum, 1346
    Norway

    Site Not Available

  • Kristiansand, 4604
    Norway

    Site Not Available

  • Lillehammer, 2609
    Norway

    Site Not Available

  • Moss, 1535
    Norway

    Site Not Available

  • Oslo, 0319
    Norway

    Site Not Available

  • empty

    Sarpsborg, 1702
    Norway

    Site Not Available

  • Bucharest, 011172
    Romania

    Site Not Available

  • Bucuresti, 020983
    Romania

    Site Not Available

  • empty

    305007, Kursk
    Russian Federation

    Site Not Available

  • Barnaul, 656024
    Russian Federation

    Site Not Available

  • Ekaterinburg, 620102
    Russian Federation

    Site Not Available

  • Irkutsk, 664047
    Russian Federation

    Site Not Available

  • Izhevsk, 426009
    Russian Federation

    Site Not Available

  • Kazan, 420012
    Russian Federation

    Site Not Available

  • Khanty-Mansiysk, 628011
    Russian Federation

    Site Not Available

  • Kursk, 305007
    Russian Federation

    Site Not Available

  • Moscow, 115522
    Russian Federation

    Site Not Available

  • Novosibirsk, 630117
    Russian Federation

    Site Not Available

  • St Petersburg, 191015
    Russian Federation

    Site Not Available

  • Tjumen, 625023
    Russian Federation

    Site Not Available

  • UFA, 450005
    Russian Federation

    Site Not Available

  • Ulyanovsk, 432063
    Russian Federation

    Site Not Available

  • Vladivostok, 690105
    Russian Federation

    Site Not Available

  • Belgrade, 11000
    Serbia

    Site Not Available

  • Kragujevac, 34000
    Serbia

    Site Not Available

  • Niska Banja, 18250
    Serbia

    Site Not Available

  • Nova sad, 21000
    Serbia

    Site Not Available

  • empty

    Novi Sad, 21000
    Serbia

    Site Not Available

  • Oviedo, Asturias 33006
    Spain

    Site Not Available

  • La Coruna, La Coruña 15006
    Spain

    Site Not Available

  • Santiago De Compostela, La Coruña 15706
    Spain

    Site Not Available

  • Leganes, Madrid 28191
    Spain

    Site Not Available

  • Bilbao, Vizcaya 48013
    Spain

    Site Not Available

  • Barcelona, 08003
    Spain

    Site Not Available

  • Madrid, 28041
    Spain

    Site Not Available

  • Sevilla, 41009
    Spain

    Site Not Available

  • Goeteborg, 41345
    Sweden

    Site Not Available

  • Umea, 90185
    Sweden

    Site Not Available

  • Bangkok, 10300
    Thailand

    Site Not Available

  • Khon Kaen, 40002
    Thailand

    Site Not Available

  • Pathumthani, 12120
    Thailand

    Site Not Available

  • Cannock, WS11 5XY
    United Kingdom

    Site Not Available

  • Glasgow, G12 0YN
    United Kingdom

    Site Not Available

  • Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • London, SE5 9RS
    United Kingdom

    Site Not Available

  • Newcastle-upon-Tyne, NE2 4HH
    United Kingdom

    Site Not Available

  • Norwich, NR4 7UY
    United Kingdom

    Site Not Available

  • Santa Monica, California 90404
    United States

    Site Not Available

  • Upland, California 91786
    United States

    Site Not Available

  • empty

    Van Nuys, California 91405
    United States

    Site Not Available

  • Whittier, California 90606
    United States

    Site Not Available

  • Aventura, Florida 33180
    United States

    Site Not Available

  • empty

    Hialeah, Florida 33016
    United States

    Site Not Available

  • empty

    Miami, Florida 33173
    United States

    Site Not Available

  • Naples, Florida 34102
    United States

    Site Not Available

  • Orange Park, Florida 32073
    United States

    Site Not Available

  • Plantation, Florida 33317
    United States

    Site Not Available

  • Sarasota, Florida 34239
    United States

    Site Not Available

  • South Miami, Florida 33143
    United States

    Site Not Available

  • Tamarac, Florida 33321
    United States

    Site Not Available

  • Eagan, Minnesota 55121
    United States

    Site Not Available

  • Las Vegas, Nevada 89128
    United States

    Site Not Available

  • Mayfield, Ohio 44143
    United States

    Site Not Available

  • Middleburg Heights, Ohio 44130
    United States

    Site Not Available

  • Oklahoma City, Oklahoma 73104
    United States

    Site Not Available

  • West Reading, Pennsylvania 19611
    United States

    Site Not Available

  • empty

    Wyomissing, Pennsylvania 19610
    United States

    Site Not Available

  • Greenville, South Carolina 29601
    United States

    Site Not Available

  • Nashville, Tennessee 37205
    United States

    Site Not Available

  • Houston, Texas 77004
    United States

    Site Not Available

  • San Antonio, Texas 78217
    United States

    Site Not Available

  • Spokane, Washington 99204
    United States

    Site Not Available

Map preview placeholder

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.