Fingolimod Real World Experience: the French Grand-Est Cohort

Multiple Sclerosis Clinical Trial

— Gilenya  

Official title:

Fingolimod Real World Experience: the French Grand-Est Cohort

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02799199
• Other study ID #: PO14105
• Status: Completed
• Phase: N/A
• First received: May 27, 2016
• Last updated: June 13, 2016
• Start date: September 2014
• Est. completion date: October 2015

Study information

• Verified date: June 2016
• Source: CHU de Reims
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission nationale de l'informatique et des libertés
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1014
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients with MS treated with Gilenya because of the disease

Exclusion Criteria:

• contraindications of Gilenya treatment or receiving Gilenya after the 31st of March 2014

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Reims

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the course of the disease by magnetic resonance imaging (MRI)		assessed between January 2012 and September 2014, up to a total of 32 months	No