Study to Assess the Efficacy and Safety of Rituximab in Patients With Rheumatoid Arthritis
NCT ID: NCT00074438
Last Updated: 2013-05-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
465 participants
INTERVENTIONAL
2003-06-30
2011-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
methotrexate
Oral or parenteral repeating dose
rituximab
Intravenous repeating dose
2
methotrexate
Oral or parenteral repeating dose
rituximab
Intravenous repeating dose
corticosteroids
Intravenous repeating dose
3
methotrexate
Oral or parenteral repeating dose
rituximab
Intravenous repeating dose
corticosteroids
Intravenous repeating dose
4
methotrexate
Oral or parenteral repeating dose
rituximab
Intravenous repeating dose
5
methotrexate
Oral or parenteral repeating dose
rituximab
Intravenous repeating dose
corticosteroids
Intravenous repeating dose
6
methotrexate
Oral or parenteral repeating dose
rituximab
Intravenous repeating dose
corticosteroids
Intravenous repeating dose
7
methotrexate
Oral or parenteral repeating dose
placebo
Intravenous repeating dose
8
methotrexate
Oral or parenteral repeating dose
corticosteroids
Intravenous repeating dose
placebo
Intravenous repeating dose
9
methotrexate
Oral or parenteral repeating dose
corticosteroids
Intravenous repeating dose
placebo
Intravenous repeating dose
Interventions
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methotrexate
Oral or parenteral repeating dose
rituximab
Intravenous repeating dose
corticosteroids
Intravenous repeating dose
placebo
Intravenous repeating dose
Eligibility Criteria
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Inclusion Criteria
* 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).
18 Years
80 Years
ALL
No
Sponsors
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Roche Pharma AG
INDUSTRY
Genentech, Inc.
INDUSTRY
Responsible Party
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References
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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.
Other Identifiers
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WA17043
Identifier Type: -
Identifier Source: secondary_id
WA17043/U2644g
Identifier Type: -
Identifier Source: org_study_id
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