An Observational Study of Glucocorticoid Use in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab)

November 1, 2016 updated by: Hoffmann-La Roche

Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.

This observational study will evaluate the glucocorticoid sparing effect after 12 months of treatment with RoActemra/Actemra (tocilizumab) in patients with rheumatoid arthritis. Data will be collected for 12 months after the initiation of treatment with RoActemra/Actemra from patients who had been on treatment with >5 mg prednisone or equivalent for at least 3 months .

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

322

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Abbeville, France, 80142
      • Agen, France, 47923
      • Aix En Provence, France, 13616
      • Aix Les Bains, France, 73106
      • Alencon, France, 61000
      • Amiens, France, 80000
      • Amiens, France, 80054
      • Angers, France, 49933
      • Argenteuil, France, 95107
      • Auch, France, 32008
      • Aulnay Sous Bois, France, 93602
      • Avignon, France, 84902
      • Bayonne, France, 64109
      • Belfort, France, 90016
      • Belley, France, 01306
      • Berck, France, 62608
      • Besancon, France, 25030
      • Blois, France, 41016
      • Bobigny, France, 93009
      • Bois Colombes, France, 92270
      • Bondy, France, 93143
      • Bordeaux, France, 33076
      • Brest, France, 29609
      • Caen, France, 14033
      • Cahors, France, 46005
      • Cahors, France, 46000
      • Cambrai, France, 59407
      • Cannes, France, 06401
      • Carcassonne, France, 11890
      • Chambray Les Tours, France, 37171
      • Clermont-ferrand, France, 63003
      • Compiegne, France, 60321
      • Corbeil Essonnes, France, 91106
      • Corbeil-essones, France, 91106
      • Dijon, France, 21000
      • Dole, France, 39108
      • Druex, France, 28102
      • Evian Les Bains, France, 74500
      • Evreux, France, 27023
      • Evry, France, 91024
      • Frejus, France, 83608
      • GAP, France, 05000
      • Gleize, France, 69400
      • La Roche Sur Yon, France, 85925
      • Laon, France, 02001
      • Lavaur, France, 81500
      • Le Coudray, France, 28630
      • Le Kremlin Bicetre, France, 94275
      • Libourne, France, 33505
      • Lievin, France, 62806
      • Lille, France, 59037
      • Limoges, France, 87042
      • Lomme, France, 59462
      • Lorient, France, 56322
      • Lyon, France, 69437
      • Lyon, France, 69002
      • Lyon, France, 69365
      • Lyon, France, 69275
      • Lyon cedex 3, France, 69437
      • Maisons Laffitte, France, 78600
      • Mandelieu La Napoule, France, 06210
      • Marseille, France, 13285
      • Marseille, France, 13385
      • Marseille, France, 13274
      • Marseille, France, 13384
      • Marseille, France, 13015
      • Meaux, France, 77104
      • Metz Tessy, France, 74370
      • Montauban, France, 82017
      • Montpellier, France, 34295
      • Morlaix, France, 29672
      • Moulins, France, 03000
      • Mulhouse, France, 68070
      • Nanterre, France, 92014
      • Nantes, France, 44035
      • Narbonne, France, 11108
      • Nice, France, 06202
      • Nimes, France, 30029
      • Niort, France, 79021
      • Paris, France, 75651
      • Paris, France, 75475
      • Paris, France, 75674
      • Paris, France, 75571
      • Paris, France, 75877
      • Paris, France, 75960
      • Perpignan, France, 66046
      • Pierre Benite, France, 69495
      • Poissy, France, 78303
      • Pontoise, France, 95300
      • Reims, France, 51092
      • Rodez, France, 12027
      • Roubaix, France, 59056
      • Saint Flour, France, 15100
      • Salon De Provence, France, 13658
      • St Chamond, France, 42403
      • St Mande, France, 94163
      • St Nazaire, France, 44606
      • St Priest En Jarez, France, 42277
      • St Quentin, France, 02109
      • Ste Maxime, France, 83120
      • Suresnes, France, 92151
      • Thionville, France, 57126
      • Toulon, France, 83056
      • Toulon, France, 83041
      • Toulon, France, 83000
      • Toulon, France, 83100
      • Toulouse, France, 31059
      • Toulouse, France, 31076
      • Toulouse, France, 31077
      • Tourcoing, France, 59208
      • Valenciennes, France, 59322
      • Vandoeuvre-les-nancy, France, 54511
      • Vannes, France, 56017
      • Vienne, France, 38209
      • Villefranche Sur Saone, France, 69400
      • Villeurbanne, France, 69626
      • Vlleneuve Sur Lot, France, 47307

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Rheumatoid arthritis patients on treatment with RoActemra/Actemra and > 5 mg/day prednisone (or equivalent)

Description

Inclusion Criteria:

  • Adult patients, >/= 18 years of age
  • Patients with rheumatoid arthritis for whom the rheumatologist decided to introduce RoActemra
  • Patients taking more than 5 mg/day of oral prednisone (or equivalent) for at least 3 months

Exclusion Criteria:

  • Participation in a clinical trial in rheumatoid arthritis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Cohort

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra
Time Frame: approximately 29 months
approximately 29 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Efficacy: Disease activity score (DAS 28)
Time Frame: approximately 29 months
approximately 29 months
Co-medications: dosage and treatment schedules
Time Frame: approximately 29 months
approximately 29 months
Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI)
Time Frame: approximately 29 months
approximately 29 months
Safety: Incidence of adverse events
Time Frame: approximately 29 months
approximately 29 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

April 1, 2013

Study Completion (Actual)

April 1, 2013

Study Registration Dates

First Submitted

July 8, 2011

First Submitted That Met QC Criteria

July 11, 2011

First Posted (Estimate)

July 12, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ML25634

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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