Fingolimod Real World Experience: the French Grand-Est Cohort

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02799199

Acronym

Gilenya

Enrollment

1014

Registered

2016-06-14

Start date

2014-09-30

Completion date

2015-10-31

Last updated

2016-06-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
the course of the disease by magnetic resonance imaging (MRI)	assessed between January 2012 and September 2014, up to a total of 32 months

Outcome results