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
NCT ID: NCT02097745
Last Updated: 2016-11-03
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
341 participants
INTERVENTIONAL
2004-06-30
2013-06-30
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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MabThera/Rituxan
methotrexate
a 10-25 mg stable dose given orally or parenterally throughout study
rituximab [MabThera/Rituxan]
1 g given by intravenous infusion on Days 1 and 15 of each treatment course
Interventions
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methotrexate
a 10-25 mg stable dose given orally or parenterally throughout study
rituximab [MabThera/Rituxan]
1 g given by intravenous infusion on Days 1 and 15 of each treatment course
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* patients who participated in MabThera study WA17042, and completed to at least the Week 24 visit;
* eligible for re-treatment, based on clinical symptoms;
* patients of reproductive potential must be using reliable contraceptive methods.
Exclusion Criteria
* current treatment with any other disease-modifying antirheumatic drug (apart from methotrexate), 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.
18 Years
80 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
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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Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Fullerton, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Pasadena, California, United States
Rancho Mirage, California, United States
Santa Maria, California, United States
Danbury, Connecticut, United States
Boca Raton, Florida, United States
Delray Beach, Florida, United States
Fort Lauderdale, Florida, United States
Jupiter, Florida, United States
Orlando, Florida, United States
Boise, Idaho, United States
Coeur d'Alene, Idaho, United States
Meridian, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Shreverport, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Kalamazoo, Michigan, United States
Lansing, Michigan, United States
Rochester, Minnesota, United States
St Louis, Missouri, United States
St Louis, Missouri, United States
Albany, New York, United States
Manhasset, New York, United States
New York, New York, United States
Rochester, New York, United States
Smithtown, New York, United States
Chapel Hill, North Carolina, United States
Greenville, North Carolina, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Mayfield, Ohio, United States
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Tulsa, Oklahoma, United States
Duncansville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Amarillo, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Waco, Texas, United States
Salt Lake City, Utah, United States
Burlington, Vermont, United States
Seattle, Washington, United States
Seattle, Washington, United States
Spokane, Washington, United States
Madison, Wisconsin, United States
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Bois-Guillaume, , France
Le Kremlin-Bicêtre, , France
Montpellier, , France
Paris, , France
Toulouse, , France
Berlin, , Germany
Dresden, , Germany
Leipzig, , Germany
Ratingen, , Germany
Würzburg, , Germany
Cork, , Ireland
Dublin, , Ireland
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
Udine, Friuli Venezia Giulia, Italy
Brescia, Lombardy, Italy
Pisa, Tuscany, Italy
Amsterdam, , Netherlands
Drammen, , Norway
Oslo, , Norway
Tromsø, , Norway
Cannock, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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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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WA17531
Identifier Type: -
Identifier Source: org_study_id
NCT00468377
Identifier Type: -
Identifier Source: nct_alias