Multiple Sclerosis (MS)
Conditions
Brief summary
1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)
Detailed description
1. Change in Expanded Disability Status Scale (EDSS) score over time, 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time, 3. The number of new, hypointense T1 lesions and number of new or enlarging T2 lesions, 4. The change in total volume of T2 lesions and in total T1 lesion volume
Interventions
DRUGOcrevus 300 mg concentrate for solution for infusion
Sponsors
F. Hoffmann-La Roche AG
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in Expanded Disability Status Scale (EDSS) score over time, 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time, 3. The number of new, hypointense T1 lesions and number of new or enlarging T2 lesions, 4. The change in total volume of T2 lesions and in total T1 lesion volume | — |
Countries
Austria, Belgium, Bulgaria, Croatia, Czechia, Estonia, Finland, France, Germany, Hungary, Italy, Latvia, Lithuania, Netherlands, Poland, Portugal, Romania, Slovakia, Spain, Sweden
Outcome results
None listed