An Global Comparative Observational Study of RoActemra/Actemra (Tocilizumab) in Patients With Rheumatoid Arthritis

NCT ID: NCT01543503

Last Updated: 2016-02-10

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1225 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2015-02-28

Brief Summary

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This prospective, multi-center, observational study will assess the efficacy and safety of treatment in patients who are treated with a TNF Inhibitor or RoActemra/Actemra (tocilizumab) as the first biologic therapy. Data will be collected for 52 weeks.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Adult patients, \>/=18 years of age
* Diagnosis of rheumatoid arthritis
* Non-respondent or intolerant to non-biologic disease-modifying anti-rheumatic drug (DMARD) therapy
* Patient has been prescribed a first biologic therapy up to 6 weeks prior to the inclusion visit, irrespective of the treatment prescribed

Exclusion Criteria

* Patients whose first biologic therapy is given as part of a clinical trial studying rheumatoid arthritis (RA) treatment
* Patients who are receiving or have received experimental DMARDs as part of a clinical trial studying RA treatment in the last 12 months
* Patients whose first biologic is rituximab, abatacept or anakinra.
* Patients who have received any biologic therapy for more than 6 weeks prior to the inclusion visit
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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Catamarca Capital, , Argentina

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Mendoza, , Argentina

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Mendoza, , Argentina

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Rosario, , Argentina

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Aalst, , Belgium

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Assebroek, , Belgium

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Aye, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Genk, , Belgium

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Ghent, , Belgium

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Godinne, , Belgium

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Heusy, , Belgium

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Liège, , Belgium

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Ostend, , Belgium

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Verviers, , Belgium

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Westmalle, , Belgium

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Barranquilla, , Colombia

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Bogotá, , Colombia

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Bucaramanga, , Colombia

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Medellín, , Colombia

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Cuenca, , Ecuador

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Esmeraldas, , Ecuador

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Guayaquil, , Ecuador

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Portoviejo, , Ecuador

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Quito, , Ecuador

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Quito, , Ecuador

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Quito, , Ecuador

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Aachen, , Germany

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Bad Aibling, , Germany

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Bad Neuenahr-Ahrweiler, , Germany

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Bayreuth, , Germany

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Berlin, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Erfurt, , Germany

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Erlangen, , Germany

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Fulda, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Heidelberg, , Germany

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Herne, , Germany

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Ludwigsfelde, , Germany

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München, , Germany

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München, , Germany

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Passau, , Germany

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Rostock, , Germany

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Stuttgart, , Germany

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Traunstein, , Germany

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Wuppertal, , Germany

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Athens, , Greece

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Athens, , Greece

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Pátrai, , Greece

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Thessaloniki, , Greece

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Thessaloniki, , Greece

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Guatemala City, , Guatemala

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Coppito, Abruzzo, Italy

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Pescara, Abruzzo, Italy

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Brindisi, Apulia, Italy

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Martina Franca, Apulia, Italy

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San Cesario di Lecce, Apulia, Italy

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Reggio Calabria, Calabria, Italy

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Avellino, Campania, Italy

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Napoli, Campania, Italy

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Napoli, Campania, Italy

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Salerno, Campania, Italy

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Udine, Friuli Venezia Giulia, Italy

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Rome, Lazio, Italy

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Rome, Lazio, Italy

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Arenzano, Liguria, Italy

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Brescia, Lombardy, Italy

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Legnano, Lombardy, Italy

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Milan, Lombardy, Italy

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Milan, Lombardy, Italy

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Agnone, Molise, Italy

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Turin, Piedmont, Italy

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Turin, Piedmont, Italy

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Catania, Sicily, Italy

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Jesi Ancona, The Marches, Italy

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Prato, Tuscany, Italy

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Perugia, Umbria, Italy

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Guadalajara, , Mexico

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Mexicali, , Mexico

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Mexico Ctiy, , Mexico

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Panama City, , Panama

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Almada, , Portugal

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Amadora, , Portugal

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Lisbon, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Porto, , Portugal

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Vila Nova de Gaia, , Portugal

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Fuenlabrada, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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Madrid, Madrid, Spain

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San Sebastián de los Reyes, Madrid, Spain

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Aarau, , Switzerland

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Basel, , Switzerland

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Chur, , Switzerland

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Sankt Gallen, , Switzerland

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Donetsk, , Ukraine

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Kharkiv, , Ukraine

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Kmelnytskyy, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Odesa, , Ukraine

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Uzhhorod, , Ukraine

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Zaporizhzhya, , Ukraine

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Barnsley, , United Kingdom

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Basildon, , United Kingdom

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Basingstoke, , United Kingdom

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Brighton, , United Kingdom

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Cannock, , United Kingdom

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Cardiff, , United Kingdom

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Chertsey, , United Kingdom

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Crawley, , United Kingdom

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Darlington, , United Kingdom

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Enfield, , United Kingdom

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Grimsby, , United Kingdom

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Guildford, , United Kingdom

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Ipswich, , United Kingdom

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Kettering, , United Kingdom

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Lancaster, , United Kingdom

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Leeds, , United Kingdom

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Llandudno, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Luton, , United Kingdom

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Maidstone, , United Kingdom

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Margate, , United Kingdom

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Metropolitan Borough of Wirral, , United Kingdom

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North Shields, , United Kingdom

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Oswestry, , United Kingdom

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Plymouth, , United Kingdom

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Portsmouth, , United Kingdom

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Reading, , United Kingdom

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Rhyl, , United Kingdom

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Romford, , United Kingdom

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Sheffield, , United Kingdom

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Stockport, , United Kingdom

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Sunderland, , United Kingdom

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Swindon, , United Kingdom

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Torquay, , United Kingdom

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Warrington, , United Kingdom

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Wolverhampton, , United Kingdom

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Wrightington, , United Kingdom

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Montevideo, , Uruguay

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Montevideo, , Uruguay

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Countries

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Argentina Belgium Colombia Ecuador Germany Greece Guatemala Italy Mexico Panama Portugal Spain Switzerland Ukraine United Kingdom Uruguay

References

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Choy EH, Bernasconi C, Aassi M, Molina JF, Epis OM. Treatment of Rheumatoid Arthritis With Anti-Tumor Necrosis Factor or Tocilizumab Therapy as First Biologic Agent in a Global Comparative Observational Study. Arthritis Care Res (Hoboken). 2017 Oct;69(10):1484-1494. doi: 10.1002/acr.23303. Epub 2017 Sep 6.

Reference Type DERIVED
PMID: 28622454 (View on PubMed)

Other Identifiers

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MA27950

Identifier Type: -

Identifier Source: org_study_id

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