An Observational Study of RoActemra/Actemra (Tocilizumab) As Monotherapy in Rheumatoid Arthritis Patients in Routine Clinical Practice

NCT ID: NCT01474291

Last Updated: 2016-10-28

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

608 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2014-09-30

Brief Summary

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

This prospective, multi-center, observational study will evaluate factors influencing the use of tocilizumab (RoActemra/Actemra) as monotherapy in rheumatoid arthritis patients in real life setting. Data will be collected from participants for 12 months following initiation of tocilizumab treatment.

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.

Tocilizumab

Tocilizumab administered as monotherapy or in combination with other standard of care therapy according to prescribing information and normal clinical practice.

Tocilizumab

Intervention Type BIOLOGICAL

Tocilizumab administered according to prescribing information and normal clinical practice.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Tocilizumab

Tocilizumab administered according to prescribing information and normal clinical practice.

Intervention Type BIOLOGICAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

RoActemra® Actemra®

Eligibility Criteria

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

Inclusion Criteria

* Adult participants, \>/= 18 years of age
* Patients with rheumatoid arthritis for whom the rheumatologist decides to start tocilizumab in combination with DMARD or as monotherapy

Exclusion Criteria

* Current participation in a clinical trial in rheumatoid arthritis
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.

Aix-les-Bains, , France

Site Status

Amiens, , France

Site Status

Amiens, , France

Site Status

Angers, , France

Site Status

Auch, , France

Site Status

Aulnay-sous-Bois, , France

Site Status

Avignon, , France

Site Status

Bastia, , France

Site Status

Bayonne, , France

Site Status

Beauvais, , France

Site Status

Belfort, , France

Site Status

Belley, , France

Site Status

Berck, , France

Site Status

Besançon, , France

Site Status

Bobigny, , France

Site Status

Bois-Guillaume, , France

Site Status

Bondy, , France

Site Status

Bonneville, , France

Site Status

Bordeaux, , France

Site Status

Bordeaux, , France

Site Status

Boulogne-Billancourt, , France

Site Status

Bressuire, , France

Site Status

Brest, , France

Site Status

Bry-sur-Marne, , France

Site Status

Caen, , France

Site Status

Cahors, , France

Site Status

Cannes, , France

Site Status

Carcassonne, , France

Site Status

Chambray-lès-Tours, , France

Site Status

Chambray-lès-Tours, , France

Site Status

Châteauroux, , France

Site Status

Clermont-Ferrand, , France

Site Status

Colmar, , France

Site Status

Compiègne, , France

Site Status

Corbeil-essones, , France

Site Status

Corbeil-Essonnes, , France

Site Status

Créteil, , France

Site Status

Denain, , France

Site Status

Digne-les-Bains, , France

Site Status

Dijon, , France

Site Status

Dole, , France

Site Status

Draguignan, , France

Site Status

Druex, , France

Site Status

Échirolles, , France

Site Status

Épernay, , France

Site Status

Évian-les-Bains, , France

Site Status

Évreux, , France

Site Status

Évry, , France

Site Status

Freyming-Merlebach, , France

Site Status

Fréjus, , France

Site Status

Gap, , France

Site Status

Gleizé, , France

Site Status

Haguenau, , France

Site Status

Ivry-sur-Seine, , France

Site Status

Laon, , France

Site Status

Lavaur, , France

Site Status

Le Bouscat, , France

Site Status

Le Coudray, , France

Site Status

Le Kremlin-Bicêtre, , 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

Lyon, , France

Site Status

Lyon, , France

Site Status

Maisons-Laffitte, , France

Site Status

Marseille, , France

Site Status

Marseille, , France

Site Status

Marseille, , France

Site Status

Metz-Tessy, , France

Site Status

Montauban, , France

Site Status

Montpellier, , France

Site Status

Moulins, , France

Site Status

Mulhouse, , France

Site Status

Nanterre, , France

Site Status

Nantes, , France

Site Status

Narbonne, , France

Site Status

Nevers, , France

Site Status

Nice, , France

Site Status

Nîmes, , France

Site Status

Orange, , 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

Périgueux, , France

Site Status

Pierre-Bénite, , France

Site Status

Poissy, , France

Site Status

Pontoise, , France

Site Status

Reims, , France

Site Status

Rennes, , France

Site Status

Rodez, , France

Site Status

Roubaix, , France

Site Status

Saint-Brieuc, , France

Site Status

Saint-Chamond, , France

Site Status

Saint-Mandé, , France

Site Status

Saint-Priest-en-Jarez, , France

Site Status

Salon-de-Provence, , France

Site Status

Ste Maxime, , France

Site Status

Strasbourg, , France

Site Status

Suresnes, , France

Site Status

Thionville, , France

Site Status

Toulon, , France

Site Status

Toulouse, , France

Site Status

Toulouse, , France

Site Status

Toulouse, , France

Site Status

Tourcoing, , France

Site Status

Valenciennes, , France

Site Status

Valenciennes, , France

Site Status

Vandœuvre-lès-Nancy, , France

Site Status

Vannes, , France

Site Status

Villeneuve-Saint-Georges, , France

Site Status

Villeurbanne, , France

Site Status

Vlleneuve Sur Lot, , France

Site Status

Countries

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

Monaco France

References

Explore related publications, articles, or registry entries linked to this study.

Flipo RM, Maillefert JF, Chazerain P, Idier I, Coudert M, Tebib J. Factors influencing the use of tocilizumab as monotherapy in patients with rheumatoid arthritis in a real-life setting: results at 1 year of the ACT-SOLO study. RMD Open. 2017 Jan 10;3(1):e000340. doi: 10.1136/rmdopen-2016-000340. eCollection 2017.

Reference Type DERIVED
PMID: 28123778 (View on PubMed)

Other Identifiers

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

ML27873

Identifier Type: -

Identifier Source: org_study_id