A Study of the Efficacy and Safety of Re-treatments With Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Anti-tnfa Therapies

Last updated: September 14, 2016
Sponsor: Hoffmann-La Roche
Overall Status: Completed

Phase

3

Condition

Musculoskeletal Diseases

Dermatomyositis (Connective Tissue Disease)

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT02097745
WA17531
  • Ages 18-80
  • All Genders

Study Summary

This study will assess the long-term safety and efficacy of repeating treatment with MabThera, in combination with methotrexate and steroids, in patients who were previously randomized into MabThera study WA17042. The anticipated time on study treatment is until Mabthera is available on the local market and the target sample size is 100-500 individuals.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • adult patients 18-80 years of age with active RA;

  • patients who participated in MabThera study WA17042, and completed to at least theWeek 24 visit;

  • eligible for re-treatment, based on clinical symptoms;

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

Exclusion

Exclusion Criteria:

  • patients who participated in MabThera study WA17042 but withdrew into the safetyfollow-up;

  • current treatment with any other disease-modifying antirheumatic drug (apart frommethotrexate), or any anti-TNFalfa, anti-IL1, or other biologic therapies;

  • development of any new contraindications to receiving MabThera;

  • women who are pregnant or breast-feeding.

Study Design

Total Participants: 341
Study Start date:
June 01, 2004
Estimated Completion Date:
June 30, 2013

Connect with a study center

  • Bruxelles, 1200
    Belgium

    Site Not Available

  • Gent, 9000
    Belgium

    Site Not Available

  • Calgary, Alberta T2N 4Z6
    Canada

    Site Not Available

  • Edmonton, Alberta T6G 2S2
    Canada

    Site Not Available

  • Hamilton, Ontario L8N 2B6
    Canada

    Site Not Available

  • London, Ontario N6A 4V2
    Canada

    Site Not Available

  • Toronto, Ontario M4N 3M5
    Canada

    Site Not Available

  • Bois Guillaume, 76233
    France

    Site Not Available

  • Le Kremlin Bicetre, 94275
    France

    Site Not Available

  • Montpellier, 34295
    France

    Site Not Available

  • Paris, 75679
    France

    Site Not Available

  • Toulouse, 31059
    France

    Site Not Available

  • Berlin, 10117
    Germany

    Site Not Available

  • Dresden, 01067
    Germany

    Site Not Available

  • Leipzig, 04103
    Germany

    Site Not Available

  • Ratingen, 40882
    Germany

    Site Not Available

  • empty

    Wuerzburg, 97080
    Germany

    Site Not Available

  • Würzburg, 97080
    Germany

    Site Not Available

  • Cork,
    Ireland

    Site Not Available

  • Dublin, 4
    Ireland

    Site Not Available

  • Haifa, 3109601
    Israel

    Site Not Available

  • Jerusalem, 9112001
    Israel

    Site Not Available

  • Petach Tikva, 4941492
    Israel

    Site Not Available

  • Ramat Gan, 5262000
    Israel

    Site Not Available

  • Tel Aviv, 6423906
    Israel

    Site Not Available

  • Udine, Friuli-Venezia Giulia 33100
    Italy

    Site Not Available

  • Brescia, Lombardia 25123
    Italy

    Site Not Available

  • Pisa, Toscana 56100
    Italy

    Site Not Available

  • Amsterdam, 1105 AZ
    Netherlands

    Site Not Available

  • Drammen, 3004
    Norway

    Site Not Available

  • Oslo, 0370
    Norway

    Site Not Available

  • Tromsø, 9038
    Norway

    Site Not Available

  • Cannock, WS11 5XY
    United Kingdom

    Site Not Available

  • Leeds, LS7 4SA
    United Kingdom

    Site Not Available

  • London, E11 1NR
    United Kingdom

    Site Not Available

  • Manchester, M41 5SL
    United Kingdom

    Site Not Available

  • Newcastle Upon Tyne, NE1 4LP
    United Kingdom

    Site Not Available

  • Mesa, Arizona 85208
    United States

    Site Not Available

  • Paradise Valley, Arizona 85253
    United States

    Site Not Available

  • Tucson, Arizona 85724
    United States

    Site Not Available

  • Little Rock, Arkansas 72205
    United States

    Site Not Available

  • Fullerton, California 92835
    United States

    Site Not Available

  • Los Angeles, California 90045
    United States

    Site Not Available

  • Pasadena, California 91105
    United States

    Site Not Available

  • Rancho Mirage, California 92270
    United States

    Site Not Available

  • Santa Maria, California 93454
    United States

    Site Not Available

  • Danbury, Connecticut 06810
    United States

    Site Not Available

  • Boca Raton, Florida 33486
    United States

    Site Not Available

  • Delray Beach, Florida 33484
    United States

    Site Not Available

  • Fort Lauderdale, Florida 33334
    United States

    Site Not Available

  • Jupiter, Florida 33458
    United States

    Site Not Available

  • Orlando, Florida 32806
    United States

    Site Not Available

  • Boise, Idaho 83702
    United States

    Site Not Available

  • Coeur D'alene, Idaho 83814
    United States

    Site Not Available

  • Meridian, Idaho 83642
    United States

    Site Not Available

  • Chicago, Illinois 60637
    United States

    Site Not Available

  • Indianapolis, Indiana 46260
    United States

    Site Not Available

  • Shreverport, Louisiana 71103
    United States

    Site Not Available

  • Baltimore, Maryland 21224
    United States

    Site Not Available

  • Boston, Massachusetts 02215
    United States

    Site Not Available

  • Kalamazoo, Michigan 49048
    United States

    Site Not Available

  • Lansing, Michigan 48910
    United States

    Site Not Available

  • Rochester, Minnesota 55905
    United States

    Site Not Available

  • Saint Louis, Missouri 63141
    United States

    Site Not Available

  • St Louis, Missouri 63110
    United States

    Site Not Available

  • Albany, New York 12206
    United States

    Site Not Available

  • Manhasset, New York 11030
    United States

    Site Not Available

  • New York, New York 10003
    United States

    Site Not Available

  • Smithtown, New York 11787
    United States

    Site Not Available

  • Chapel Hill, North Carolina 27599-7600
    United States

    Site Not Available

  • Greenville, North Carolina 27834
    United States

    Site Not Available

  • Cincinnati, Ohio 45267-0563
    United States

    Site Not Available

  • Dayton, Ohio 45402
    United States

    Site Not Available

  • Mayfield, Ohio 44143
    United States

    Site Not Available

  • Oklahoma City, Oklahoma 73109
    United States

    Site Not Available

  • Tulsa, Oklahoma 74135
    United States

    Site Not Available

  • Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Philadelphia, Pennsylvania 19152
    United States

    Site Not Available

  • Amarillo, Texas 79124
    United States

    Site Not Available

  • Dallas, Texas 75246
    United States

    Site Not Available

  • Houston, Texas 77074
    United States

    Site Not Available

  • Waco, Texas 76710
    United States

    Site Not Available

  • Salt Lake City, Utah 84132
    United States

    Site Not Available

  • Burlington, Vermont 05401
    United States

    Site Not Available

  • Seattle, Washington 98104
    United States

    Site Not Available

  • Spokane, Washington 99204
    United States

    Site Not Available

  • Madison, Wisconsin 53792
    United States

    Site Not Available

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.