Patients with relapsing-remitting multiple sclerosis with less than 10 years disease duration.
Conditions
Brief summary
The binary indicator of at least one treatment-related SAE (relationship ≥ possible) per participant.
Detailed description
Proportion of patients with a new MRI lesion at end of follow-up; and the average number of new T2 lesions per patient., Proportion of patients with a new relapse; and the proportion of patients with a steroid-treated relapse; and the annualized relapse rate during follow-up,, Proportion of patients with confirmed disability worsening; and the average change in EDSS (Expanded Disability Status Scale); and proportion of patients with worsened/unchanged/improved SDMT; and the average change in SDMT., The average change in pNfL and pGFAp., Proportion of patients with improved MSIS-29; and the average change in MSIS-29., Proportion of patients with mild/moderate adverse events with at least a probable relationship to the study medication (adverse reaction)
Interventions
Sponsors
Region Uppsala
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The binary indicator of at least one treatment-related SAE (relationship ≥ possible) per participant. | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a new MRI lesion at end of follow-up; and the average number of new T2 lesions per patient., Proportion of patients with a new relapse; and the proportion of patients with a steroid-treated relapse; and the annualized relapse rate during follow-up,, Proportion of patients with confirmed disability worsening; and the average change in EDSS (Expanded Disability Status Scale); and proportion of patients with worsened/unchanged/improved SDMT; and the average change in SDMT., The average change in pNfL and pGFAp., Proportion of patients with improved MSIS-29; and the average change in MSIS-29., Proportion of patients with mild/moderate adverse events with at least a probable relationship to the study medication (adverse reaction) | — |
Countries
Sweden
Outcome results
None listed