Multiple sclerosis
Conditions
Brief summary
Percentage of patients with no new or enlarging T2 white matter lesions from month 6 to month 24
Detailed description
Percentage of patients with 6-month confirmed disease worsening (CDW) in EDSS from baseline to month 24 (m24) • ARR based on cumulative number of confirmed relapses from baseline to m24 • Percentage of patients with 6-months CDW in T25FW, 9HPT and SDMT from baseline to m24 • Change in MSIS-29, FSMC, EQ-5D from baseline to m24 • Percentage of patients without GdEL on m6 and m24 scans • Change in T2 and T1 white matter lesion volume from m6 to m24 • Difference in serum NFL from baseline to m24
Interventions
DRUGOcrevus 300 mg concentrate for solution for infusion
Sponsors
Rigshospitalet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of patients with no new or enlarging T2 white matter lesions from month 6 to month 24 | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with 6-month confirmed disease worsening (CDW) in EDSS from baseline to month 24 (m24) • ARR based on cumulative number of confirmed relapses from baseline to m24 • Percentage of patients with 6-months CDW in T25FW, 9HPT and SDMT from baseline to m24 • Change in MSIS-29, FSMC, EQ-5D from baseline to m24 • Percentage of patients without GdEL on m6 and m24 scans • Change in T2 and T1 white matter lesion volume from m6 to m24 • Difference in serum NFL from baseline to m24 | — |
Countries
Denmark
Outcome results
None listed