An Observational Study of MabThera/Rituxan (Rituximab) and Alternative TNF-Inhibitors in Patients With Rheumatoid Arthritis and an Inadequate Response to a Single Previous TNF-Inhibitor

NCT ID: NCT01557348

Last Updated: 2017-01-24

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

1239 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-06-30

Study Completion Date

2012-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This multicenter, prospective, observational study will assess the efficacy of MabThera/Rituxan (rituximab) and alternative TNF-inhibitors in patients with rheumatoid arthritis who are non-responders or intolerant to a single previous TNF-inhibitor. Data will be collected from each patient from the time of change in biologic therapy for 12 months.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Rituximab

Eligible participants will receive rituximab as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.

No interventions assigned to this group

Alternative TNFi

Eligible participants will receive alternative TNFi treatment as second biologic therapy in routine clinical practice and were observed for 12 months from the start of the second biologic therapy.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients, \>/= 18 years of age
* Patients with rheumatoid arthritis (RA) who have not responded or have been intolerant to a single TNF-inhibitor therapy
* Initiated on treatment with MabThera/Rituxan or an alternative TNF-inhibitor therapy, in accordance with the relevant Summary of Product Characteristics

Exclusion Criteria

* Patients whose second biologic therapy is given as part of a clinical trial studying RA treatment
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Winnipeg, Manitoba, Canada

Site Status

Saint John, New Brunswick, Canada

Site Status

Brampton, Ontario, Canada

Site Status

Burlington, Ontario, Canada

Site Status

Hamilton, Ontario, Canada

Site Status

Kitchener, Ontario, Canada

Site Status

London, Ontario, Canada

Site Status

Mississauga, Ontario, Canada

Site Status

St. Catharines, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Toronto, Ontario, Canada

Site Status

Windsor, Ontario, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Montreal, Quebec, Canada

Site Status

Rimouski, Quebec, Canada

Site Status

Saskatoon, Saskatchewan, Canada

Site Status

Barranquilla, , Colombia

Site Status

Bogotá, , Colombia

Site Status

Cali, , Colombia

Site Status

Abbeville, , France

Site Status

Aix-les-Bains, , France

Site Status

Amiens, , France

Site Status

Amiens, , France

Site Status

Argenteuil, , France

Site Status

Bayonne, , France

Site Status

Belfort, , France

Site Status

Besançon, , France

Site Status

Bonneville, , France

Site Status

Bordeaux, , France

Site Status

Bordeaux, , France

Site Status

Boulogne-Billancourt, , France

Site Status

Brest, , France

Site Status

Bruges, , France

Site Status

Bry-sur-Marne, , France

Site Status

Caen, , France

Site Status

Cahors, , France

Site Status

Cambrai, , France

Site Status

Cannes, , France

Site Status

Carcassonne, , France

Site Status

Carhaix-Plouguer, , France

Site Status

Chambray-lès-Tours, , France

Site Status

Clermont-Ferrand, , France

Site Status

Clermont-Ferrand, , France

Site Status

Colmar, , France

Site Status

Corbeil-Essonnes, , France

Site Status

Draguignan, , France

Site Status

Échirolles, , France

Site Status

Évreux, , France

Site Status

Issy-les-Moulineaux, , France

Site Status

La Roche-sur-Yon, , France

Site Status

La Source, , France

Site Status

Laon, , France

Site Status

Laval, , France

Site Status

Le Coudray, , France

Site Status

Le Kremlin-Bicêtre, , France

Site Status

Le Mans, , France

Site Status

Libourne, , France

Site Status

Liévin, , France

Site Status

Lille, , France

Site Status

Limoges, , France

Site Status

Limoges, , France

Site Status

Lomme, , France

Site Status

Lorient, , France

Site Status

Lyon, , France

Site Status

Lyon, , France

Site Status

Lyon, , France

Site Status

Maisons-Laffitte, , France

Site Status

Mantes-la-Jolie, , France

Site Status

Marseille, , France

Site Status

Marseille, , France

Site Status

Mennecy, , France

Site Status

Metz, , France

Site Status

Montauban, , France

Site Status

Montauban, , France

Site Status

Montivilliers, , France

Site Status

Montpellier, , France

Site Status

Mulhouse, , France

Site Status

Nantes, , France

Site Status

Nevers, , France

Site Status

Nice, , France

Site Status

Pachuca, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Paris, , France

Site Status

Perpignan, , France

Site Status

Pierre-Bénite, , France

Site Status

Reims, , France

Site Status

Reims, , France

Site Status

Rennes, , France

Site Status

Rodez, , France

Site Status

Roubaix, , France

Site Status

Saint-Aubin-lès-Elbeuf, , France

Site Status

Saint-Brieuc, , France

Site Status

Saint-Priest-en-Jarez, , France

Site Status

Toulon, , France

Site Status

Toulouse, , France

Site Status

Toulouse, , France

Site Status

Tours, , France

Site Status

Valence, , France

Site Status

Valenciennes, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Vannes, , France

Site Status

Villeneuve-sur-Lot, , France

Site Status

Vincennes, , France

Site Status

Aachen, , Germany

Site Status

Bremen, , Germany

Site Status

Cologne, , Germany

Site Status

Cuxhaven, , Germany

Site Status

Erlangen, , Germany

Site Status

Frankenberg, , Germany

Site Status

Frankfurt, , Germany

Site Status

Gräfelfing, , Germany

Site Status

Halle, , Germany

Site Status

Hanover, , Germany

Site Status

Münster, , Germany

Site Status

Neuss, , Germany

Site Status

Rostock, , Germany

Site Status

Villingen-Schwenningen, , Germany

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Athens, , Greece

Site Status

Larissa, , Greece

Site Status

Coppito, Abruzzo, Italy

Site Status

Bari, Apulia, Italy

Site Status

San Cesario di Lecce, Apulia, Italy

Site Status

Potenza, Basilicate, Italy

Site Status

Napoli, Campania, Italy

Site Status

Telese Terme, Campania, Italy

Site Status

Ferrara, Emilia-Romagna, Italy

Site Status

Modena, Emilia-Romagna, Italy

Site Status

Udine, Friuli Venezia Giulia, Italy

Site Status

Milan, Lombardy, Italy

Site Status

Milan, Lombardy, Italy

Site Status

Gazzi, Sicily, Italy

Site Status

Palermo, Sicily, Italy

Site Status

Ancona, The Marches, Italy

Site Status

Iesi, The Marches, Italy

Site Status

Florence, Tuscany, Italy

Site Status

Pisa, Tuscany, Italy

Site Status

Prato, Tuscany, Italy

Site Status

Siena, Tuscany, Italy

Site Status

Padua, Veneto, Italy

Site Status

Verona, Veneto, Italy

Site Status

Chihuahua City, , Mexico

Site Status

Mexicali, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Mexico City, , Mexico

Site Status

Poza Rica Chacas, , Mexico

Site Status

Monaco, , Monaco

Site Status

Ålesund, , Norway

Site Status

Amadora, , Portugal

Site Status

Guimarães, , Portugal

Site Status

Lisbon, , Portugal

Site Status

Porto, , Portugal

Site Status

Córdoba, Cordoba, Spain

Site Status

Granada, Granada, Spain

Site Status

Granada, Granada, Spain

Site Status

León, Leon, Spain

Site Status

Lugo, Lugo, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

Madrid, Madrid, Spain

Site Status

El Palmar, Murcia, Spain

Site Status

Lorca, Murcia, Spain

Site Status

Salamanca, Salamanca, Spain

Site Status

Seville, Sevilla, Spain

Site Status

Torrevieja, , Spain

Site Status

Abergavenny, , United Kingdom

Site Status

Aylesbury, , United Kingdom

Site Status

Blackburn, , United Kingdom

Site Status

Cambridge, , United Kingdom

Site Status

Cannock, , United Kingdom

Site Status

Cardiff, , United Kingdom

Site Status

Cheltenham, , United Kingdom

Site Status

Chertsey, , United Kingdom

Site Status

Cosham, , United Kingdom

Site Status

Derby, , United Kingdom

Site Status

Durham, , United Kingdom

Site Status

Exeter, , United Kingdom

Site Status

Glasgow, , United Kingdom

Site Status

Harrogate, , United Kingdom

Site Status

Inverness, , United Kingdom

Site Status

Lancaster, , United Kingdom

Site Status

Leeds, , United Kingdom

Site Status

Lincoln, , United Kingdom

Site Status

Liverpool, , United Kingdom

Site Status

London, , United Kingdom

Site Status

London, , United Kingdom

Site Status

London, , United Kingdom

Site Status

Manchester, , United Kingdom

Site Status

Metropolitan Borough of Wirral, , United Kingdom

Site Status

Poole, , United Kingdom

Site Status

Salford, , United Kingdom

Site Status

Solihull, , United Kingdom

Site Status

Southport, , United Kingdom

Site Status

St Helens, , United Kingdom

Site Status

Stockport, , United Kingdom

Site Status

Sunderland, , United Kingdom

Site Status

Sutton in Ashfield, , United Kingdom

Site Status

Torquay, , United Kingdom

Site Status

Truro, , United Kingdom

Site Status

Warrington, , United Kingdom

Site Status

Wolverhampton, , United Kingdom

Site Status

Worthing, , United Kingdom

Site Status

Wrightington, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada Colombia France Germany Greece Italy Mexico Monaco Norway Portugal Spain United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MA22401

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.