MS multiple sclerosis
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Age * 18 years 2. Diagnosis of MS according to any version of the McDonald criteria 3. Being treated with anti-CD20 mAb in the context of MS 4. Having received at least 4 cycles with anti-CD20 mAb 5. No signs of clinical or radiological disease activity in the preceding 1 year
Exclusion criteria
Exclusion criteria: 1. Inability to comply with yearly MRI and 6-monthly clinical monitoring 2. Inability to make an informed treatment decision because of language barriers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the proportion of pwMS with new and/or enhancing T2 lesions on brain MRI. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary endpoints are the proportion of pwMS with symptomatic infections requiring hospital admission, relapses, confirmed disability progression, NEDA-3, timed 25-foot walk test, nine hole peg test, single digit modality test, serum neurofilament level evolution, SARS-CoV-2 antibodies, lymphocyte repopulation and immunoglobulin level evolution. We will also record the reasons to prioritize induction vs. continuation of maintenance therapy with anti-CD20. | — |
Countries
Netherlands
Outcome results
None listed