A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis Who Have Failed on One Prior Anti-TNF Therapy (RESET)
NCT ID: NCT01272908
Last Updated: 2017-08-15
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
120 participants
INTERVENTIONAL
2006-07-18
2009-03-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single arm
rituximab
1000 mg intravenously on Days 1 and 15
Interventions
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rituximab
1000 mg intravenously on Days 1 and 15
Eligibility Criteria
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Inclusion Criteria
* Moderate to severe active rheumatoid arthritis
* Inadequate response to a single previous or current treatment with an anti-TNF agent
* Methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks
Exclusion Criteria
* Use of an anti-TNF agent within past 8 weeks (4 in the case of etanercept)
* Concurrent treatment with any Disease Modifying Anti-Rheumatic Drug (DMARD) other than methotrexate
* Active infection, or history of serious or chronic infection
18 Years
80 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_CHAIR
Hoffmann-La Roche
Locations
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Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Kelowna, British Columbia, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
St. John's, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Hamilton, Ontario, Canada
Hamilton, Ontario, Canada
Mississauga, Ontario, Canada
Nepean, Ontario, Canada
Ottawa, Ontario, Canada
Ottawa, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Laval, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Saint-Eustache, Quebec, Canada
Sainte-Foy, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Borås, , Sweden
Falun, , Sweden
Gothenburg, , Sweden
Jönköping, , Sweden
Kalmar, , Sweden
Karlskrona, , Sweden
Luleå, , Sweden
Malmo, , Sweden
Oskarström, , Sweden
Skövde, , Sweden
Stockholm, , Sweden
Sundsvall, , Sweden
Countries
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Other Identifiers
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ML20381
Identifier Type: -
Identifier Source: org_study_id
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