A Study to Evaluate the Safety and Efficacy of MabThera (Rituximab) in Combination With Methotrexate (MTX) in Participants With Active Rheumatoid Arthritis Who Failed on Anti-Tumor Necrosis Factor Alpha Therapy
NCT ID: NCT00468546
Last Updated: 2016-10-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
520 participants
INTERVENTIONAL
2003-05-31
2012-07-31
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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Placebo Plus Methotrexate
Participants will be administered placebo by intravenous infusion on Days 1 and 15 along with MTX 10-25 mg per os (p.o.) or parenterally once a week up to 24 weeks and will be followed up to Week 104.
Methotrexate
2
Placebo
3
Rituximab plus Methotrexate
Participants will be administered rituximab 1000 mg as intravenous infusion on Days 1 and 15 along with MTX 10-25 mg p.o. or parenterally once a week up to Week 24 and will be followed up to Week 104.
MabThera/Rituxan
1
Methotrexate
2
Interventions
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MabThera/Rituxan
1
Methotrexate
2
Placebo
3
Eligibility Criteria
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Inclusion Criteria
* Received treatment for RA on an outpatient basis and experienced an inadequate response or intolerance to treatment with at least 1 anti-TNF alpha therapy (etanercept, infliximab or adalimumab);
* Must have received MTX for a minimum of 12 weeks, with the last 4 weeks, prior to screening at a stable dose;
* Participants with swollen joint count (SJC) and tender joint count (TJC) of at least 8 joints at screening and at randomization;
* Radiographic evidence of at least 1 joint with a definite erosion due to RA;
* Participants of reproductive potential must be using reliable contraceptive methods.
Exclusion Criteria
* Class IV functional status of RA;
* Previous treatment within 6 months with intravenous gamma globulin, or the Prosorba column;
* Intraarticular or parenteral corticosteroids within 4 weeks prior to screening visit;
* With a live vaccine within 4 weeks prior to randomization;
* Previous treatment with rituximab or other cell-depleting therapies;
* Concurrent treatment with any disease-modifying anti-rheumatic drug (except for MTX) or any anti-TNF alfa factor or other biologic therapy;
* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies;
* Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal disorders;
* Known contraindications to receiving rituximab;
* Known active bacterial, viral, fungal, mycobacterial or other infection;
* History of recurrent significant infection or history of recurrent bacterial infections;
* Primary or secondary immunodeficiency (history of, or currently active);
* History of cancer, including solid tumors and hematologic malignancies (except basal cell or squamous cell carcinoma of the skin that have been excised and cured);
* Women who are pregnant or breast-feeding;
* History of alcohol, drug or chemical abuse within 6 months prior to screening;
* Neuropathies and neurovasculopathies which might interfere with pain evaluation;
* Participants with poor peripheral venous access;
* Intolerance or contraindications to oral or intravenous corticosteroids.
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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Birmingham, Alabama, United States
Mesa, Arizona, United States
Paradise Valley, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
Fullerton, California, United States
La Jolla, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Palo Alto, California, United States
Pasadena, California, United States
Rancho Mirage, California, United States
Santa Maria, California, United States
Upland, 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
Largo, 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
Durham, North Carolina, United States
Greenville, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, 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
Madison, Wisconsin, United States
Brussels, , Belgium
Brussels, , Belgium
Ghent, , Belgium
Liège, , Belgium
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
London, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Le Kremlin-Bicêtre, , France
Montpellier, , France
Paris, , France
Rouen, , France
Strasbourg, , France
Toulouse, , France
Tours, , 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
Arenzano, Liguria, Italy
Genoa, Liguria, Italy
Brescia, Lombardy, Italy
Milan, Lombardy, Italy
Pisa, Tuscany, Italy
Amsterdam, , Netherlands
Drammen, , Norway
Lillehammer, , Norway
Oslo, , Norway
Tromsø, , Norway
Cannock, , United Kingdom
Leeds, , United Kingdom
London, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Countries
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References
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Lal P, Su Z, Holweg CT, Silverman GJ, Schwartzman S, Kelman A, Read S, Spaniolo G, Monroe JG, Behrens TW, Townsend MJ. Inflammation and autoantibody markers identify rheumatoid arthritis patients with enhanced clinical benefit following rituximab treatment. Arthritis Rheum. 2011 Dec;63(12):3681-91. doi: 10.1002/art.30596.
Keystone E, Burmester GR, Furie R, Loveless JE, Emery P, Kremer J, Tak PP, Broder MS, Yu E, Cravets M, Magrini F, Jost F. Improvement in patient-reported outcomes in a rituximab trial in patients with severe rheumatoid arthritis refractory to anti-tumor necrosis factor therapy. Arthritis Rheum. 2008 Jun 15;59(6):785-93. doi: 10.1002/art.23715.
Other Identifiers
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102-20
Identifier Type: OTHER
Identifier Source: secondary_id
WA17042
Identifier Type: -
Identifier Source: org_study_id
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