Relapsing-remitting Multiple Sclerosis
Conditions
Brief summary
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 )
Interventions
OTHERNon interventional study
Not applicable - Non interventional Study
Sponsors
Nantes University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relapse within first year of treatment | 12 months | Proportion of patients experimenting at least one relapse within the first year of treatment |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of clinical event at Two years | 24 months | Proportion of patients with at least one relapse at two years of treatment |
| Progression of disability | 12 months and 24 months | Proportion of patients with a progression of disability defined by any increased of EDSS score compared to baseline |
| Radiological disease activity | 12 months and 24 months | 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 |
| Adverse drug reaction | 12 months and 24 months | Number and description of adverse reaction. Proportion of patients who had stopped treatment due to AR |
Countries
France
Outcome results
None listed