Multiple sclerosis
Conditions
Brief summary
The % of patients without disease activity between D0 and M36. Disease activity is defined as 1) the presence of at least one clinical relapse between inclusion and M36 AND/OR 2) Brain MRI activity defined as at least 1 new/enlarged T2/FLAIR lesion on MRI scans between baseline MRI and M36.
Detailed description
Relapses, Disability, New/enlarged T2/FLAIR lesions, Adverse event and severe adverse events, Infections and serious infections, B-cells counts, Serum immunoglobulin levels (IgG, A, M), Brain volume, Neurofilaments light chain values, EQ5D-5L score, MUSICARE score, Incremental cost-utility ratio at year 3, Annual budget impact from the SNDS (Système National des Données de Santé hosted by French Health Insurance)
Interventions
DRUGOFATUMUMAB
DRUGDIMETHYL FUMARATE
DRUGOCRELIZUMAB
DRUGGLATIRAMER ACETATE
DRUGTERIFLUNOMIDE
DRUGINTERFERON BETA-1A
DRUGRITUXIMAB
Sponsors
Centre Hospitalier Universitaire De Montpellier
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The % of patients without disease activity between D0 and M36. Disease activity is defined as 1) the presence of at least one clinical relapse between inclusion and M36 AND/OR 2) Brain MRI activity defined as at least 1 new/enlarged T2/FLAIR lesion on MRI scans between baseline MRI and M36. | — |
Secondary
| Measure | Time frame |
|---|---|
| Relapses, Disability, New/enlarged T2/FLAIR lesions, Adverse event and severe adverse events, Infections and serious infections, B-cells counts, Serum immunoglobulin levels (IgG, A, M), Brain volume, Neurofilaments light chain values, EQ5D-5L score, MUSICARE score, Incremental cost-utility ratio at year 3, Annual budget impact from the SNDS (Système National des Données de Santé hosted by French Health Insurance) | — |
Countries
France
Outcome results
None listed