Extension Study to Assess the Efficacy and Safety of Repeat Treatment With Rituximab (MabThera) in Participants With Active Rheumatoid Arthritis (RA)
NCT ID: NCT02093026
Last Updated: 2017-03-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
465 participants
INTERVENTIONAL
2002-08-31
2012-12-31
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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Rituximab
Participants will receive rituximab 1 gram intravenously (IV) on Days 1 and 15 of each course of retreatment. In addition, participants will receive methotrexate 10-25 milligrams per week (mg/week) orally or parenterally, methylprednisolone 100 mg IV 30 minutes prior to both rituximab infusions, and a stable dose of folic acid greater than or equal to (\>=) 5 mg/week or equivalent. Participants will receive retreatment (next course of rituximab repeat treatment) within 2 weeks of meeting the retreatment criteria as defined in the protocol (minimum of 24 weeks after the first \[Day 1\] infusion of the last course of rituximab). Repeat treatment will be based on the investigator's decision of prior clinical response to rituximab, clinical need and evidence of active disease (Disease Activity Score in 28 joints \>=2.6). Retreatment with rituximab will be continued until withdrawal of consent or study treatment completion on 31 December 2011, whichever is sooner.
Rituximab
Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment.
Methotrexate
Participants will receive methotrexate 10-25 mg/week orally or parenterally.
Methylprednisolone
Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion.
Folic Acid
Participants will receive folic acid \>= 5 mg/week or equivalent.
Interventions
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Rituximab
Participants will receive rituximab 1 gram IV on Days 1 and 15 of each course of retreatment.
Methotrexate
Participants will receive methotrexate 10-25 mg/week orally or parenterally.
Methylprednisolone
Participants will receive methylprednisolone 100 mg IV 30 minutes prior to each rituximab infusion.
Folic Acid
Participants will receive folic acid \>= 5 mg/week or equivalent.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* completed 24 weeks of treatment in WA16291 or WA17043
* eligible for re-treatment, based on clinical symptoms (Disease Activity Score in 28 joints \>=2.6)
* females of childbearing potential using reliable contraception
Exclusion Criteria
* previous rituximab non-responders
* current treatment with any other disease-modifying drug (apart from methotrexate), or any anti-tumor necrosis factor alfa, anti-interleukin-1, or other biologic therapies
* participants with known active infection of any kind
* evidence of any new or uncontrolled concomitant disease or development of any new contraindications which would preclude repeat treatment with rituximab
* history of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
* female participants who are pregnant or breastfeeding
21 Years
ALL
No
Sponsors
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Genentech, Inc.
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
Peoria, Arizona, United States
Little Rock, Arkansas, United States
La Jolla, California, United States
Long Beach, California, United States
Rancho Mirage, California, United States
San Diego, California, United States
Colorado Springs, Colorado, United States
Aventura, Florida, United States
Boca Raton, Florida, United States
Fort Lauderdale, Florida, United States
Largo, Florida, United States
South Miami, Florida, United States
Boise, Idaho, United States
Chicago, Illinois, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Indianapolis, Indiana, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
St Louis, Missouri, United States
Lebanon, New Hampshire, United States
Voorhees Township, New Jersey, United States
Great Neck, New York, United States
Plainview, New York, United States
Rochester, New York, United States
Smithtown, New York, United States
Greenville, North Carolina, United States
Winston-Salem, North Carolina, United States
Beachwood, Ohio, United States
Dayton, Ohio, United States
Mayfield, Ohio, United States
Tulsa, Oklahoma, United States
Tulsa, Oklahoma, United States
Portland, Oregon, United States
Duncansville, Pennsylvania, United States
Dallas, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Glendale, Wisconsin, United States
Wausau, Wisconsin, United States
Maroochydore, Queensland, Australia
Melbourne, Victoria, Australia
Perth, Western Australia, Australia
Ghent, , Belgium
Curtiba, Paraná, Brazil
Campinas, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Calgary, Alberta, Canada
Vancouver, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
London, Ontario, Canada
Prague, , Czechia
Heinola, , Finland
Helsinki, , Finland
Cologne, , Germany
Leipzig, , Germany
Ratingen, , Germany
Regensburg, , Germany
Würzburg, , Germany
Haifa, , Israel
Haifa, , Israel
Modena, Emilia-Romagna, Italy
Udine, Friuli Venezia Giulia, Italy
Genoa, Liguria, Italy
Milan, Lombardy, Italy
Mexico City, , Mexico
Mexico City, , Mexico
México, , Mexico
Monterrey, , Mexico
Auckland, , New Zealand
Auckland, , New Zealand
Bialystok, , Poland
Lublin, , Poland
Poznan, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Mérida, Badajoz, Spain
Santiago de Compostela, La Coruña, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Seville, Sevilla, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Gothenburg, , Sweden
Stockholm, , Sweden
Birmingham, , United Kingdom
Cambridge, , United Kingdom
Cannock, , United Kingdom
Leeds, , United Kingdom
Stoke-on-Trent, , United Kingdom
Countries
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Other Identifiers
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U2653g
Identifier Type: OTHER
Identifier Source: secondary_id
WA16855
Identifier Type: -
Identifier Source: org_study_id
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