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

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

934 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-03-31

Study Completion Date

2012-04-30

Brief Summary

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This study was an extension to study MA21573 \[NCT00750880\], which was an open label single arm study to investigate the safety, tolerability and efficacy of tocilizumab monotherapy, or combination therapy with non-biological disease-modifying antirheumatic drugs (DMARDS), in patients with moderate to severe active rheumatoid arthritis. Patients who completed the 24 week core study, and had at least a moderate European League Against Rheumatism (EULAR) response, were eligible to enter this long-term extension study, and received tocilizumab 8 mg/kg intravenous (iv) every 4 weeks. The anticipated time on study treatment was 1-2 years, and the target sample size was \> 500 individuals.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

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.

Group Type EXPERIMENTAL

tocilizumab [RoActemra/Actemra]

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

\- patients who completed the 24-week MA21573 core study, had at least a moderate response based on EULAR definition criteria and no adverse events (AEs), serious adverse events (SAEs) or conditions that led to unacceptable risk of continued treatment.

Exclusion Criteria

-as for MA21573.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Canberra, Australian Capital Territory, Australia

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Coffs Harbour, New South Wales, Australia

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Kogarah, New South Wales, Australia

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Cairns, Queensland, Australia

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Adelaide, South Australia, Australia

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Fitzroy, Victoria, Australia

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Geelong, Victoria, Australia

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Melbourne, Victoria, Australia

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Edmonton, Alberta, Canada

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Lethbridge, Alberta, Canada

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Kelowna, British Columbia, Canada

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Nanaimo, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Quispamsis, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Hamilton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Windsor, Ontario, Canada

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Laval, Quebec, Canada

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Montreal, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Rimouski, Quebec, Canada

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Saint-Eustache, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Saskatoon, Saskatchewan, Canada

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Bruntál, , Czechia

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Ostrava, , Czechia

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Prague, , Czechia

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Sokolov, , Czechia

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Uherské Hradiště, , Czechia

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Zlín, , Czechia

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Belfort, , France

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Caen, , France

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Cahors, , France

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Corbeil-Essonnes, , France

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Dijon, , France

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La Rochelle, , France

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Liévin, , France

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Lomme, , France

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Lyon, , France

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Lyon, , France

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Marseille, , France

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Montivilliers, , France

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Montpellier, , France

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Mulhouse, , France

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Paris, , France

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Poitiers, , France

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Reims, , France

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Roubaix, , France

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Saint-Brieuc, , France

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Strasbourg, , France

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Toulouse, , France

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Valence, , France

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Valenciennes, , France

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Heraklion, , Greece

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Budapest, , Hungary

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Eger, , Hungary

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Szeged, , Hungary

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Veszprém, , Hungary

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Arenzano, , Italy

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Legnano, , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Modena, , Italy

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Monserrato, , Italy

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Novara, , Italy

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Palermo, , Italy

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Potenza, , Italy

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Roma, , Italy

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Roma, , Italy

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Siena, , Italy

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Varese, , Italy

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's-Hertogenbosch, , Netherlands

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Alkmaar, , Netherlands

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Amsterdam, , Netherlands

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Apeldoorn, , Netherlands

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Arnhem, , Netherlands

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Bergen op Zoom, , Netherlands

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Den Helder, , Netherlands

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Enschede, , Netherlands

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Flushing, , Netherlands

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Gouda, , Netherlands

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Heerlen, , Netherlands

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Hilversum, , Netherlands

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Leeuwarden, , Netherlands

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Nieuwegein, , Netherlands

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Nijmegen, , Netherlands

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Roosendaal, , Netherlands

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Rotterdam, , Netherlands

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Rotterdam, , Netherlands

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Schiedam, , Netherlands

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Spijkenisse, , Netherlands

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The Hague, , Netherlands

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The Hague, , Netherlands

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Krakow, , Poland

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Poznan, , Poland

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Wroclaw, , Poland

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Almada, , Portugal

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Coimbra, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Bucharest, , Romania

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Bucharest, , Romania

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Cluj-Napoca, , Romania

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Jeddah, , Saudi Arabia

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Jeddah, , Saudi Arabia

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Jeddah, , Saudi Arabia

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Alicante, Alicante, Spain

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Elche, Alicante, Spain

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Elda, Alicante, Spain

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Almería, Almeria, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Barcelona, Barcelona, Spain

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Sabadell, Barcelona, Spain

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Terrassa, Barcelona, Spain

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Cáceres, Caceres, Spain

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Córdoba, Cordoba, Spain

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Granada, Granada, Spain

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Huesca, Huesca, Spain

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A Coruña, La Coruña, Spain

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Las Palmas de Gran Canaria, Las Palmas, Spain

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Lugo, Lugo, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Málaga, Malaga, Spain

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Salamanca, Salamanca, Spain

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Seville, Sevilla, Spain

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San Cristóbal de La Laguna, Tenerife, Spain

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Valencia, Valencia, Spain

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Valencia, Valencia, Spain

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Barnsley, , United Kingdom

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Basingstoke, , United Kingdom

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Bournemouth, , United Kingdom

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Brighton, , United Kingdom

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Burton-on-Trent, , United Kingdom

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Bury Saint Edmonds, , United Kingdom

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Cambridge, , United Kingdom

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Cardiff, , United Kingdom

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Chelmsford, , United Kingdom

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Dudley, , United Kingdom

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Eastbourne, , United Kingdom

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Gillingham, , United Kingdom

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Harrogate, , United Kingdom

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Ipswich, , United Kingdom

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Liverpool, , United Kingdom

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Llantrisant, , United Kingdom

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London, , United Kingdom

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Londonderry, , United Kingdom

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Maidstone, , United Kingdom

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Metropolitan Borough of Wirral, , United Kingdom

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Middlesbrough, , United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Nottingham, , United Kingdom

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Reading, , United Kingdom

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Salford, , United Kingdom

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Sheffield, , United Kingdom

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Southport, , United Kingdom

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Swindon, , United Kingdom

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Torquay, , United Kingdom

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Westcliffe-on-sea, , United Kingdom

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Worthing, , United Kingdom

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Countries

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Australia Canada Czechia France Greece Hungary Italy Netherlands Poland Portugal Romania Saudi Arabia Spain United Kingdom

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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