Clinical trial NCT01392001: An Observational Study of Glucocorticoid Use in Patients With Rheumatoid Arthritis on Treatment With RoActemra/Actemra (Tocilizumab)
Official title: Evaluation of Glucocorticoid Sparing Effect in Patients Receiving RoActemra® for Rheumatoid Arthritis in Real Life.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2011-07-12
Enrollment: 322
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Rheumatoid arthritis patients on treatment with RoActemra/Actemra and \> 5 mg/day prednisone (or equivalent)

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 .


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients receiving </= 5 mg/day prednisone (or equivalent) after 12 months of treatment with RoActemra/Actemra
timeFrame: approximately 29 months
Secondary outcomes:
measure: Efficacy: Disease activity score (DAS 28)
timeFrame: approximately 29 months
measure: Co-medications: dosage and treatment schedules
timeFrame: approximately 29 months
measure: Patient reported outcome: European League against Rheumatism - Rheumatoid Arthritis Impact of Disease score (EULAR-RAID)/Health Assessment Questionnaire - Disease Index (HAQ-DI)
timeFrame: approximately 29 months
measure: Safety: Incidence of adverse events
timeFrame: approximately 29 months
Other outcomes:
Locations:
city: Abbeville
country: France
city: Agen
country: France
city: Aix En Provence
country: France
city: Aix Les Bains
country: France
city: Alencon
country: France
city: Amiens
country: France
city: Amiens
country: France
city: Angers
country: France
city: Argenteuil
country: France
city: Auch
country: France
city: Aulnay Sous Bois
country: France
city: Avignon
country: France
city: Bayonne
country: France
city: Belfort
country: France
city: Belley
country: France
city: Berck
country: France
city: Besancon
country: France
city: Blois
country: France
city: Bobigny
country: France
city: Bois Colombes
country: France
city: Bondy
country: France
city: Bordeaux
country: France
city: Brest
country: France
city: Caen
country: France
city: Cahors
country: France
city: Cahors
country: France
city: Cambrai
country: France
city: Cannes
country: France
city: Carcassonne
country: France
city: Chambray Les Tours
country: France
city: Clermont-ferrand
country: France
city: Compiegne
country: France
city: Corbeil Essonnes
country: France
city: Corbeil-essones
country: France
city: Dijon
country: France
city: Dole
country: France
city: Druex
country: France
city: Evian Les Bains
country: France
city: Evreux
country: France
city: Evry
country: France
city: Frejus
country: France
city: GAP
country: France
city: Gleize
country: France
city: La Roche Sur Yon
country: France
city: Laon
country: France
city: Lavaur
country: France
city: Le Coudray
country: France
city: Le Kremlin Bicetre
country: France
city: Libourne
country: France
city: Lievin
country: France
city: Lille
country: France
city: Limoges
country: France
city: Lomme
country: France
city: Lorient
country: France
city: Lyon cedex 3
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Lyon
country: France
city: Maisons Laffitte
country: France
city: Mandelieu La Napoule
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Marseille
country: France
city: Meaux
country: France
city: Metz Tessy
country: France
city: Montauban
country: France
city: Montpellier
country: France
city: Morlaix
country: France
city: Moulins
country: France
city: Mulhouse
country: France
city: Nanterre
country: France
city: Nantes
country: France
city: Narbonne
country: France
city: Nice
country: France
city: Nimes
country: France
city: Niort
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Paris
country: France
city: Perpignan
country: France
city: Pierre Benite
country: France
city: Poissy
country: France
city: Pontoise
country: France
city: Reims
country: France
city: Rodez
country: France
city: Roubaix
country: France
city: Saint Flour
country: France
city: Salon De Provence
country: France
city: St Chamond
country: France
city: St Mande
country: France
city: St Nazaire
country: France
city: St Priest En Jarez
country: France
city: St Quentin
country: France
city: Ste Maxime
country: France
city: Suresnes
country: France
city: Thionville
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulon
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Toulouse
country: France
city: Tourcoing
country: France
city: Valenciennes
country: France
city: Vandoeuvre-les-nancy
country: France
city: Vannes
country: France
city: Vienne
country: France
city: Villefranche Sur Saone
country: France
city: Villeurbanne
country: France
city: Vlleneuve Sur Lot
country: France
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: