Comparison of Oral Molecules Preventing Relapses in Multiple Sclerosis

Nantes University Hospital3,000 enrolled

Overview

The aim of this observational study is to compare Dimethyl fumarate (DMF) and Teriflunomide on both clinical and MRI outcomes in patients with relapsing-remitting multiple sclerosis (RRMS) from French Observatory of Multiple Sclerosis (French MS cohort )

Study Type

OBSERVATIONAL

Enrollment

3,000

Conditions

Relapsing-remitting Multiple Sclerosis

Interventions

Non interventional studyOTHER

Not applicable - Non interventional Study

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * RRMS Patients with an EDSS score ranging between 0 and 5.5, who initiated either DMF or Teriflunomide before 1/01/2016 and with an available MRI scan and EDSS assessment respectively within 12 and 6 months before treatment initiation Patients who had consent to OFSEP registry Naive patient or treated with prior first line treatment : interferon, glatiramer acetate Exclusion Criteria: * Patient with progressive multiple sclerosis * Patients with prior second line Patient with no MRI or EDSS score within the year before DMF or Teriflunomide initiation.

Locations (1)

Nantes University Hospital

Nantes, France

Outcomes

Primary Outcomes

Relapse within first year of treatment

Proportion of patients experimenting at least one relapse within the first year of treatment

Time frame: 12 months

Secondary Outcomes

Occurrence of clinical event at Two years

Proportion of patients with at least one relapse at two years of treatment

Time frame: 24 months

Progression of disability

Proportion of patients with a progression of disability defined by any increased of EDSS score compared to baseline

Time frame: 12 months and 24 months

Radiological disease activity

Proportion of patients with at least one Gd-enhancing lesion and the proportion of patients with at least one new T2-lesion on MRI scans compared to baseline MRI scan Probablity

Time frame: 12 months and 24 months

Adverse drug reaction

Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR

Time frame: 12 months and 24 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.