An Exploratory Study of Tocilizumab in Patients With Active Rheumatoid Arthritis (RA) and an Inadequate Response to Current Non-Biologic DMARDs and/or Anti-TNF Therapy.

NCT ID: NCT00750880

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1681 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2011-07-31

Brief Summary

This open-label, single arm study will investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biologic disease modifying antirheumatic drugs (DMARDs), in patients with severe active RA. Patients will receive tocilizumab 8mg/kg iv as a 60 minute infusion every 4 weeks for a total of 6 infusions. The anticipated time on study treatment is 3-12 months, and the target sample size is >500 individuals.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type: DRUG

8mg/kg iv (60 minute infusion)

Interventions

tocilizumab [RoActemra/Actemra]

8mg/kg iv (60 minute infusion)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• male and non-pregnant or nursing female patients >=18 years of age;
• body weight <=150kg;
• moderate to severe active RA (DAS28 >=3.2) of >=6 months duration;
• on >=1 non-biologic DMARDs at a stable dose for a period of >= 8 weeks prior to start of treatment;
• inadequate clinical response to a stable dose of non-biologic DMARD or anti-TNF therapy;
• if receiving oral corticosteroids, the dose must have been stable for at least 25 of 28 days prior to start of treatment.

Exclusion Criteria

• major surgery (including joint surgery) within 8 weeks prior to screening or planned major surgery within 6 months following enrollment;
• rheumatic autoimmune disease other than RA;
• prior history of, or current inflammatory joint disease other than RA;
• functional class IV as defined by the ACR Classification of Functional Status in RA.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Canberra, Australian Capital Territory, Australia

Coffs Harbour, New South Wales, Australia

Kogarah, New South Wales, Australia

Parramatta Park, New South Wales, Australia

Adelaide, South Australia, Australia

Fitzroy, Victoria, Australia

Geelong, Victoria, Australia

Melbourne, Victoria, Australia

Graz, , Austria

Graz-Eggenberg, , Austria

Innsbruck, , Austria

Linz, , Austria

Salzburg, , Austria

Stockerau, , Austria

Vienna, , Austria

Vienna, , Austria

Vienna, , Austria

Aalst, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Brussels, , Belgium

Edegem, , Belgium

Ghent, , Belgium

Hasselt, , Belgium

Heusy, , Belgium

Leuven, , Belgium

Liège, , Belgium

Merksem, , Belgium

Montignies S/ Sambre, , Belgium

Westmalle, , Belgium

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

Aarhus, , Denmark

Copenhagen, , Denmark

Copenhagen, , Denmark

Esbjerg, , Denmark

Hjørring, , Denmark

Silkeborg, , Denmark

Helsinki, , Finland

Jyväskylä, , Finland

Turku, , Finland

Argenteuil, , France

Aulnay-sous-Bois, , France

Belfort, , France

Bobigny, , France

Bourg-en-Bresse, , France

Caen, , France

Cahors, , France

Colmar, , 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

Paris, , France

Pau, , France

Poitiers, , France

Reims, , France

Roubaix, , France

Saint-Brieuc, , France

Strasbourg, , France

Toulouse, , France

Valence, , France

Valenciennes, , France

Berlin, , Germany

Bielefeld, , Germany

Freiburg im Breisgau, , Germany

Greifswald, , Germany

Hamburg, , Germany

Jena, , Germany

Kiel, , Germany

Rostock, , Germany

Saarbrücken, , Germany

Wuppertal, , Germany

Würzburg, , Germany

Athens, , Greece

Heraklion, , Greece

Ioannina, , Greece

Pátrai, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Thessaloniki, , Greece

Budapest, , Hungary

Eger, , Hungary

Gyula, , Hungary

Szeged, , Hungary

Veszprém, , Hungary

Bangalore, , India

Chennai, , India

Hyderabad, , India

Jaipur, , India

Kolkata, , India

Kolkata, , India

Ludhiana, , India

Mumbai, , India

New Delhi, , India

Pune, , India

Co Leitrim, , Ireland

Cork, , Ireland

Dublin, , Ireland

Dublin, , Ireland

Dublin, , Ireland

Dublin, , Ireland

Galway, , Ireland

Limerick, , Ireland

Waterford, , Ireland

Arenzano, , Italy

Legnano, , Italy

Milan, , Italy

Milan, , Italy

Milan, , Italy

Modena, , Italy

Monserrato, , Italy

Novara, , Italy

Palermo, , Italy

Pescara, , Italy

Potenza, , Italy

Roma, , Italy

Roma, , Italy

Siena, , Italy

Varese, , Italy

Luxembourg, , Luxembourg

's-Hertogenbosch, , Netherlands

Alkmaar, , Netherlands

Amsterdam, , Netherlands

Apeldoorn, , Netherlands

Arnhem, , Netherlands

Bergen op Zoom, , Netherlands

Den Helder, , Netherlands

Enschede, , Netherlands

Flushing, , Netherlands

Gorinchem, , Netherlands

Gouda, , Netherlands

Heerlen, , Netherlands

Hilversum, , Netherlands

Leeuwarden, , Netherlands

Leidschendam, , 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

Avilés, Avila, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Barcelona, Barcelona, Spain

Sabadell, Barcelona, Spain

Terrassa, Barcelona, Spain

Vic, Barcelona, Spain

Cáceres, Caceres, Spain

Cadiz, Cadiz, Spain

Jerez de la Frontera, Cadiz, Spain

Córdoba, Cordoba, Spain

Granada, Granada, Spain

Huesca, Huesca, Spain

A Coruña, La Coruña, Spain

Las Palmas de Gran Canaria, Las Palmas, Spain

León, Leon, Spain

Ponferrada, Leon, Spain

Lugo, Lugo, Spain

Madrid, Madrid, Spain

Madrid, Madrid, Spain

Málaga, Malaga, Spain

Murcia, Murcia, Spain

Ourense, Orense, Spain

Salamanca, Salamanca, Spain

Seville, Sevilla, Spain

San Cristóbal de La Laguna, Tenerife, Spain

Santa Cruz de Tenerife, Tenerife, Spain

Valencia, Valencia, Spain

Valencia, Valencia, Spain

Zaragoza, Zaragoza, Spain

Falun, , Sweden

Huddinge, , Sweden

Karlstad, , Sweden

Linköping, , Sweden

Malmo, , Sweden

Skövde, , Sweden

Stockholm, , Sweden

Uppsala, , Sweden

Västerås, , Sweden

Aarau, , Switzerland

Basel, , Switzerland

Fribourg, , Switzerland

Geneva, , Switzerland

Lucerne, , Switzerland

Sankt Gallen, , Switzerland

Zurich, , Switzerland

Ankara, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

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

Dundee, , United Kingdom

Eastbourne, , United Kingdom

Gillingham, , United Kingdom

Harrogate, , United Kingdom

Huddersfield, , 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

Australia; Austria; Belgium; Canada; Czechia; Denmark; Finland; France; Germany; Greece; Hungary; India; Ireland; Italy; Luxembourg; Netherlands; Poland; Portugal; Romania; Saudi Arabia; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

Other Identifiers

2008-000587-17

Identifier Type: -

Identifier Source: secondary_id

MA21573

Identifier Type: -

Identifier Source: org_study_id