We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00074438
Recruitment Status : Completed
First Posted : December 15, 2003
Last Update Posted : May 9, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

December 12, 2003
December 15, 2003
May 9, 2013
June 2003
September 2004   (Final data collection date for primary outcome measure)
Proportion of patients with an ACR20 response [ Time Frame: 24 weeks ]
Not Provided
Complete list of historical versions of study NCT00074438 on ClinicalTrials.gov Archive Site
  • Proportion of patients with ACR(50,70) responses [ Time Frame: 24 weeks ]
  • Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups [ Time Frame: 24 weeks ]
Not Provided
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
Randomized, Multifactorial, Double-blind, Parallel-group, Dose-ranging Study of the Efficacy and Safety of Rituximab (MabThera®/Rituxan®) in Combination With Methotrexate in Patients With Active Rheumatoid Arthritis
This study will assess the efficacy and safety of different treatment regimens of rituximab (MabThera®/Rituxan®), corticosteroids, and placebo, combined with methotrexate (MTX), in patients with active rheumatoid arthritis (RA).
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Drug: methotrexate
    Oral or parenteral repeating dose
  • Drug: rituximab
    Intravenous repeating dose
  • Drug: corticosteroids
    Intravenous repeating dose
  • Drug: placebo
    Intravenous repeating dose
  • Experimental: 1
    Interventions:
    • Drug: methotrexate
    • Drug: rituximab
  • Experimental: 2
    Interventions:
    • Drug: methotrexate
    • Drug: rituximab
    • Drug: corticosteroids
  • Experimental: 3
    Interventions:
    • Drug: methotrexate
    • Drug: rituximab
    • Drug: corticosteroids
  • Experimental: 4
    Interventions:
    • Drug: methotrexate
    • Drug: rituximab
  • Experimental: 5
    Interventions:
    • Drug: methotrexate
    • Drug: rituximab
    • Drug: corticosteroids
  • Experimental: 6
    Interventions:
    • Drug: methotrexate
    • Drug: rituximab
    • Drug: corticosteroids
  • Placebo Comparator: 7
    Interventions:
    • Drug: methotrexate
    • Drug: placebo
  • Placebo Comparator: 8
    Interventions:
    • Drug: methotrexate
    • Drug: corticosteroids
    • Drug: placebo
  • Placebo Comparator: 9
    Interventions:
    • Drug: methotrexate
    • Drug: corticosteroids
    • Drug: placebo
Keystone E, Fleischmann R, Emery P, Furst DE, van Vollenhoven R, Bathon J, Dougados M, Baldassare A, Ferraccioli G, Chubick A, Udell J, Cravets MW, Agarwal S, Cooper S, Magrini F. Safety and efficacy of additional courses of rituximab in patients with active rheumatoid arthritis: an open-label extension analysis. Arthritis Rheum. 2007 Dec;56(12):3896-908.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
465
July 2011
September 2004   (Final data collection date for primary outcome measure)

Eligibility criteria include, but are not limited to the following:

  • Are between the ages of 18 and 80 years.
  • Have been diagnosed with rheumatoid arthritis for at least 6 months.
  • Have failed treatment (lack of efficacy) with at least 1 but no more than 5 disease-modifying anti-rheumatic drugs or biologics (other than methotrexate).
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
United States
 
NCT00074438
WA17043/U2644g
WA17043
Not Provided
Not Provided
Not Provided
Genentech, Inc.
Genentech, Inc.
Roche Pharma AG
Not Provided
Genentech, Inc.
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP