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NCT02799199 Clinical Trial

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
Secondary ID
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

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
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