Back to resultsStudy to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
methotrexate
rituximab
corticosteroids
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Rituxan, RA
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Arm 8
Arm 9
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Experimental
Placebo Comparator
Placebo Comparator
Placebo Comparator
Arm Label
1
2
3
4
5
6
7
8
9
Arm Description
Outcomes
Primary Outcome Measures
Proportion of patients with an ACR20 response
Secondary Outcome Measures
Proportion of patients with ACR(50,70) responses
Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
Full Information
NCT ID
NCT00074438
First Posted
December 12, 2003
Last Updated
May 7, 2013
Sponsor
Genentech, Inc.
Collaborators
Roche Pharma AG
1. Study Identification
Unique Protocol Identification Number
NCT00074438
Brief Title
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2013
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
September 2004 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Genentech, Inc.
Collaborators
Roche Pharma AG
4. Oversight
5. Study Description
Brief Summary
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Rituxan, RA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
465 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Experimental
Arm Title
3
Arm Type
Experimental
Arm Title
4
Arm Type
Experimental
Arm Title
5
Arm Type
Experimental
Arm Title
6
Arm Type
Experimental
Arm Title
7
Arm Type
Placebo Comparator
Arm Title
8
Arm Type
Placebo Comparator
Arm Title
9
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
methotrexate
Intervention Description
Oral or parenteral repeating dose
Intervention Type
Drug
Intervention Name(s)
rituximab
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
corticosteroids
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Proportion of patients with an ACR20 response
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with ACR(50,70) responses
Time Frame
24 weeks
Title
Proportion of patients with an ACR20 response in the medium- and high-dose corticosteroid groups
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
12. IPD Sharing Statement
Citations:
PubMed Identifier
18050221
Citation
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. doi: 10.1002/art.23059.
Results Reference
derived
Links:
URL
http://www.roche-trials.com/studyResultGet.action?studyResultNumber=WA17043&diseaseCategoryId=86&divisionName=PHA
Description
Ex-U.S. Study Information (Ex-US this trial is sponsored/managed by Hoffmann-La Roche)
Learn more about this trial
Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
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