An Extension to Study MA21573, Evaluating Tocilizumab in Patients With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biological DMARDs and/or Anti-tumor Necrosis Factor (TNF) Therapy
NCT ID: NCT00883753
Last Updated: 2014-08-06
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
934 participants
INTERVENTIONAL
2009-03-31
2012-04-30
Brief Summary
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A Study of Tocilizumab (RoActemra/Actemra) in Monotherapy or in Combination With Methotrexate or Other Non-Biologic DMARDs in Participants With Active Rheumatoid Arthritis and an Inadequate Response to Current Non-Biologic DMARD Therapy or the First Anti-TNF Biologic Agent
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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tocilizumab
Participants received tocilizumab 8 mg/kg intravenous (IV), maximum dose not exceeding 800 mg in a single infusion, every 4 weeks for up to 104 weeks or up to 4 weeks after tocilizumab became commercially available in the respective country whichever occurred first.
tocilizumab [RoActemra/Actemra]
8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.
Interventions
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tocilizumab [RoActemra/Actemra]
8 mg/kg IV (maximum dose not exceeding 800 mg in a single infusion) every 4 weeks.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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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Canberra, Australian Capital Territory, Australia
Coffs Harbour, New South Wales, Australia
Kogarah, New South Wales, Australia
Cairns, Queensland, Australia
Adelaide, South Australia, Australia
Fitzroy, Victoria, Australia
Geelong, Victoria, Australia
Melbourne, Victoria, Australia
Edmonton, Alberta, Canada
Lethbridge, Alberta, Canada
Kelowna, British Columbia, Canada
Nanaimo, British Columbia, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
Quispamsis, New Brunswick, Canada
St. John's, Newfoundland and Labrador, Canada
Hamilton, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Laval, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Rimouski, Quebec, Canada
Saint-Eustache, Quebec, Canada
Sherbrooke, Quebec, Canada
Trois-Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Bruntál, , Czechia
Ostrava, , Czechia
Prague, , Czechia
Sokolov, , Czechia
Uherské Hradiště, , Czechia
Zlín, , Czechia
Belfort, , France
Caen, , France
Cahors, , France
Corbeil-Essonnes, , France
Dijon, , France
La Rochelle, , France
Liévin, , France
Lomme, , France
Lyon, , France
Lyon, , France
Marseille, , France
Montivilliers, , France
Montpellier, , France
Mulhouse, , France
Paris, , France
Poitiers, , France
Reims, , France
Roubaix, , France
Saint-Brieuc, , France
Strasbourg, , France
Toulouse, , France
Valence, , France
Valenciennes, , France
Heraklion, , Greece
Budapest, , Hungary
Eger, , Hungary
Szeged, , Hungary
Veszprém, , Hungary
Arenzano, , Italy
Legnano, , Italy
Milan, , Italy
Milan, , Italy
Milan, , Italy
Modena, , Italy
Monserrato, , Italy
Novara, , Italy
Palermo, , Italy
Potenza, , Italy
Roma, , Italy
Roma, , Italy
Siena, , Italy
Varese, , Italy
's-Hertogenbosch, , Netherlands
Alkmaar, , Netherlands
Amsterdam, , Netherlands
Apeldoorn, , Netherlands
Arnhem, , Netherlands
Bergen op Zoom, , Netherlands
Den Helder, , Netherlands
Enschede, , Netherlands
Flushing, , Netherlands
Gouda, , Netherlands
Heerlen, , Netherlands
Hilversum, , Netherlands
Leeuwarden, , Netherlands
Nieuwegein, , Netherlands
Nijmegen, , Netherlands
Roosendaal, , Netherlands
Rotterdam, , Netherlands
Rotterdam, , Netherlands
Schiedam, , Netherlands
Spijkenisse, , Netherlands
The Hague, , Netherlands
The Hague, , Netherlands
Krakow, , Poland
Poznan, , Poland
Wroclaw, , Poland
Almada, , Portugal
Coimbra, , Portugal
Lisbon, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Bucharest, , Romania
Bucharest, , Romania
Cluj-Napoca, , Romania
Jeddah, , Saudi Arabia
Jeddah, , Saudi Arabia
Jeddah, , Saudi Arabia
Alicante, Alicante, Spain
Elche, Alicante, Spain
Elda, Alicante, Spain
Almería, Almeria, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Barcelona, Barcelona, Spain
Sabadell, Barcelona, Spain
Terrassa, Barcelona, Spain
Cáceres, Caceres, Spain
Córdoba, Cordoba, Spain
Granada, Granada, Spain
Huesca, Huesca, Spain
A Coruña, La Coruña, Spain
Las Palmas de Gran Canaria, Las Palmas, Spain
Lugo, Lugo, Spain
Madrid, Madrid, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Salamanca, Salamanca, Spain
Seville, Sevilla, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Valencia, Valencia, Spain
Valencia, Valencia, Spain
Barnsley, , United Kingdom
Basingstoke, , United Kingdom
Bournemouth, , United Kingdom
Brighton, , United Kingdom
Burton-on-Trent, , United Kingdom
Bury Saint Edmonds, , United Kingdom
Cambridge, , United Kingdom
Cardiff, , United Kingdom
Chelmsford, , United Kingdom
Dudley, , United Kingdom
Eastbourne, , United Kingdom
Gillingham, , United Kingdom
Harrogate, , United Kingdom
Ipswich, , United Kingdom
Liverpool, , United Kingdom
Llantrisant, , United Kingdom
London, , United Kingdom
Londonderry, , United Kingdom
Maidstone, , United Kingdom
Metropolitan Borough of Wirral, , United Kingdom
Middlesbrough, , United Kingdom
Newcastle upon Tyne, , United Kingdom
Nottingham, , United Kingdom
Reading, , United Kingdom
Salford, , United Kingdom
Sheffield, , United Kingdom
Southport, , United Kingdom
Swindon, , United Kingdom
Torquay, , United Kingdom
Westcliffe-on-sea, , United Kingdom
Worthing, , United Kingdom
Countries
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Other Identifiers
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2008-006924-68
Identifier Type: -
Identifier Source: secondary_id
MA22460
Identifier Type: -
Identifier Source: org_study_id
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