An Observational Study of Glucocorticoid Use in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab)
Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.
1 other identifier
observational
322
1 country
116
Brief Summary
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 .
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2011
Typical duration for all trials
116 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 8, 2011
CompletedFirst Posted
Study publicly available on registry
July 12, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedNovember 2, 2016
November 1, 2016
2.1 years
July 8, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra
approximately 29 months
Secondary Outcomes (4)
Efficacy: Disease activity score (DAS 28)
approximately 29 months
Co-medications: dosage and treatment schedules
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)
approximately 29 months
Safety: Incidence of adverse events
approximately 29 months
Study Arms (1)
Cohort
Eligibility Criteria
Rheumatoid arthritis patients on treatment with RoActemra/Actemra and \> 5 mg/day prednisone (or equivalent)
You may qualify if:
- 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
You may not qualify if:
- Participation in a clinical trial in rheumatoid arthritis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (116)
Unknown Facility
Abbeville, 80142, France
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Agen, 47923, France
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Aix-en-Provence, 13616, France
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Aix-les-Bains, 73106, France
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Alençon, 61000, France
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Amiens, 80000, France
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Amiens, 80054, France
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Angers, 49933, France
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Argenteuil, 95107, France
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Auch, 32008, France
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Aulnay-sous-Bois, 93602, France
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Avignon, 84902, France
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Bayonne, 64109, France
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Belfort, 90016, France
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Belley, 01306, France
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Berck, 62608, France
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Besançon, 25030, France
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Blois, 41016, France
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Bobigny, 93009, France
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Bois-Colombes, 92270, France
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Bondy, 93143, France
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Bordeaux, 33076, France
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Brest, 29609, France
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Caen, 14033, France
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Cahors, 46000, France
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Cahors, 46005, France
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Cambrai, 59407, France
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Cannes, 06401, France
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Carcassonne, 11890, France
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Chambray-lès-Tours, 37171, France
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Clermont-Ferrand, 63003, France
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Compiègne, 60321, France
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Corbeil-essones, 91106, France
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Corbeil-Essonnes, 91106, France
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Dijon, 21000, France
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Dole, 39108, France
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Druex, 28102, France
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Évian-les-Bains, 74500, France
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Évreux, 27023, France
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Évry, 91024, France
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Fréjus, 83608, France
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Gap, 05000, France
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Gleizé, 69400, France
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La Roche-sur-Yon, 85925, France
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Laon, 02001, France
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Lavaur, 81500, France
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Le Coudray, 28630, France
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Le Kremlin-Bicêtre, 94275, France
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Libourne, 33505, France
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Liévin, 62806, France
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Lille, 59037, France
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Limoges, 87042, France
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Lomme, 59462, France
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Lorient, 56322, France
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Lyon, 69002, France
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Lyon, 69275, France
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Lyon, 69365, France
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Lyon, 69437, France
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Maisons-Laffitte, 78600, France
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Mandelieu-la-Napoule, 06210, France
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Marseille, 13015, France
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Marseille, 13274, France
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Marseille, 13285, France
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Marseille, 13384, France
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Marseille, 13385, France
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Meaux, 77104, France
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Metz-Tessy, 74370, France
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Montauban, 82017, France
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Montpellier, 34295, France
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Morlaix, 29672, France
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Moulins, 03000, France
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Mulhouse, 68070, France
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Nanterre, 92014, France
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Nantes, 44035, France
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Narbonne, 11108, France
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Nice, 06202, France
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Niort, 79021, France
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Nîmes, 30029, France
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Paris, 75475, France
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Paris, 75571, France
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Paris, 75651, France
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Paris, 75674, France
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Paris, 75877, France
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Paris, 75960, France
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Perpignan, 66046, France
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Pierre-Bénite, 69495, France
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Poissy, 78303, France
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Pontoise, 95300, France
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Reims, 51092, France
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Rodez, 12027, France
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Roubaix, 59056, France
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Saint-Chamond, 42403, France
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Saint-Flour, 15100, France
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Saint-Mandé, 94163, France
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Saint-Nazaire, 44606, France
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Saint-Priest-en-Jarez, 42277, France
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Saint-Quentin, 02109, France
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Salon-de-Provence, 13658, France
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Ste Maxime, 83120, France
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Suresnes, 92151, France
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Thionville, 57126, France
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Toulon, 83000, France
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Toulon, 83041, France
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Toulon, 83056, France
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Toulon, 83100, France
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Toulouse, 31059, France
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Toulouse, 31076, France
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Toulouse, 31077, France
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Tourcoing, 59208, France
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Valenciennes, 59322, France
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Vandœuvre-lès-Nancy, 54511, France
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Vannes, 56017, France
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Vienne, 38209, France
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Villefranche-sur-Saône, 69400, France
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Villeurbanne, 69626, France
Unknown Facility
Vlleneuve Sur Lot, 47307, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 8, 2011
First Posted
July 12, 2011
Study Start
March 1, 2011
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
November 2, 2016
Record last verified: 2016-11