A Study of Retreatment With MabThera (Rituximab) in Combination With Methotrexate in Patients With Rheumatoid Arthritis (RA)
NCT ID: NCT00422383
Last Updated: 2015-05-04
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
378 participants
INTERVENTIONAL
2006-02-28
2013-03-31
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
rituximab [MabThera/Rituxan]
500mg iv in days 1 and 15, and 500mg iv on days 168 and 182
2
rituximab [MabThera/Rituxan]
500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182
3
rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182
Interventions
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rituximab [MabThera/Rituxan]
500mg iv in days 1 and 15, and 500mg iv on days 168 and 182
rituximab [MabThera/Rituxan]
500mg iv on days 1 and 15, and 1000mg iv on days 168 and 182
rituximab [MabThera/Rituxan]
1000mg iv on days 1 and 15 and 1000mg iv (or placebo in UK)on days 168 and 182
Eligibility Criteria
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Inclusion Criteria
* RA for \>=6 months;
* receiving outpatient treatment;
* inadequate response to methotrexate, having received and tolerated it for \>=12 weeks, with a stable dose for \>=4 weeks.
Exclusion Criteria
* inflammatory joint disease other than RA, or other systemic autoimmune disorder;
* diagnosis of juvenile arthritis, or RA before the age of 16;
* previous treatment with \>1 biologic agent, any cell-depleting therapies, or concurrent treatment with any biologic agent or DMARD other than methotrexate.
18 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_DIRECTOR
Hoffmann-La Roche
Locations
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Coffs Harbour, New South Wales, Australia
Sydney, New South Wales, Australia
Maroochydore, Queensland, Australia
Southport, Queensland, Australia
Malvern, Victoria, Australia
Melbourne, Victoria, Australia
Ghent, , Belgium
Goiânia, Goiás, Brazil
São Paulo, São Paulo, Brazil
Penticton, British Columbia, Canada
Victoria, British Columbia, Canada
Winnipeg, Manitoba, Canada
London, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Trois-Rivières, Quebec, Canada
Beijing, , China
Beijing, , China
Oulu, , Finland
Bois-Guillaume, , France
Bordeaux, , France
Dijon, , France
Le Mans, , France
Lille, , France
Montpellier, , France
Nice, , France
Paris, , France
Bad Nauheim, , Germany
Cologne, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Herne, , Germany
Osnabrück, , Germany
Ratingen, , Germany
Debrecen, , Hungary
Eger, , Hungary
Coppito, Abruzzo, Italy
Potenza, Basilicate, Italy
Ferrara, Emilia-Romagna, Italy
Reggio Emilia, Emilia-Romagna, Italy
Arenzano, Liguria, Italy
Genoa, Liguria, Italy
Pieve di Coriano, Lombardy, Italy
Turin, Piedmont, Italy
Palermo, Sicily, Italy
Pisa, Tuscany, Italy
Prato, Tuscany, Italy
Siena, Tuscany, Italy
Valeggio sul Mincio, Veneto, Italy
Amsterdam, , Netherlands
Leiden, , Netherlands
Nijmegen, , Netherlands
Auckland, , New Zealand
Christchurch, , New Zealand
Timaru, , New Zealand
Košice, , Slovakia
Piešťany, , Slovakia
Piešťany, , Slovakia
Cape Town, , South Africa
Diepkloof, , South Africa
Pretoria, , South Africa
Barcelona, Barcelona, Spain
Burgos, Burgos, Spain
León, Leon, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Gijón, Principality of Asturias, Spain
Seville, Sevilla, Spain
Kaohsiung City, , Taiwan
Taichung, , Taiwan
Taoyuan District, , Taiwan
Bangkok, , Thailand
Bangkok, , Thailand
Bangkok, , Thailand
Chiang Mai, , Thailand
Khon Kaen, , Thailand
Barnsley, , United Kingdom
Birmingham, , United Kingdom
Cambridge, , United Kingdom
Glasgow, , United Kingdom
London, , United Kingdom
Londonderry, , United Kingdom
Manchester, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Middlesbrough, , United Kingdom
Northampton, , United Kingdom
Nottingham, , United Kingdom
Reading, , United Kingdom
Truro, , United Kingdom
Wigan, , United Kingdom
Countries
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References
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Rubbert-Roth A, Tak PP, Zerbini C, Tremblay JL, Carreno L, Armstrong G, Collinson N, Shaw TM; MIRROR Trial Investigators. Efficacy and safety of various repeat treatment dosing regimens of rituximab in patients with active rheumatoid arthritis: results of a Phase III randomized study (MIRROR). Rheumatology (Oxford). 2010 Sep;49(9):1683-93. doi: 10.1093/rheumatology/keq116. Epub 2010 May 12.
Other Identifiers
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WA17044
Identifier Type: -
Identifier Source: org_study_id
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