Fingolimod Real World Experience: the French Grand-Est Cohort
- Conditions
- Multiple Sclerosis
- Registration Number
- NCT02799199
- Lead Sponsor
- CHU de Reims
- Brief Summary
Objectives: This study describes efficacy and safety of Fingolimod in patients treated for at least 6 months in the east of France from January 2011 to December 2014.
Background: The Grand-Est is a geographical region in France with a high prevalence of multiple sclerosis (more than 10000 patients registered in the European Database for Multiple Sclerosis (EDMUS) database). In this region and since January 2011, more than 1014 patients have been treated for at least 6 months with Fingolimod, the first oral therapy for patient with very active relapsing-remitting MS.
Methods: Features of patients followed up in the Grand-Est region and treated with fingolimod in the 6 university hospitals, general hospitals and private neurologists were reviewed in a retrospective study after identification of the clinical files reported in the EDMUS database.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1014
- Patients with MS treated with Gilenya because of the disease
- contraindications of Gilenya treatment or receiving Gilenya after the 31st of March 2014
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method the course of the disease by magnetic resonance imaging (MRI) assessed between January 2012 and September 2014, up to a total of 32 months
- Secondary Outcome Measures
Name Time Method