COMBAT-MS core.
Aim 1: First line RTX vs DMF/GA/IFN
- Proportion of patients EDSS ≤2.5 to 6 months confirmed EDSS ≥3 over minimum 3 years of follow up
- Proportion of patients with 6 months confirmed EDSS change +1 point among those with EDSS ≥2.5 over minimum 3 years of follow up
- Change in MSIS-29 over minimum 3 years of follow up (change from baseline; mean value ±SD)
Aim 2: First line RTX vs NTZ/FGL
- Proportion of patients EDSS ≤2.5 to 6 months confirmed EDSS ≥3 over minimum 3 years of follow up
- Proportion of patients with 6 months confirmed EDSS change +1 point among those with EDSS ≥2.5 over minimum 3 years of follow up
- Change in MSIS-29 over minimum 3 years of follow up (change from baseline; mean value ±SD)
Aim 3: Second line (switching from DMF/GA/IFN) RTX vs NTZ/FGL
- Proportion of patients EDSS ≤2.5 to 6 months confirmed EDSS ≥3 over minimum 3 years of follow up
- Proportion of patients with 6 months confirmed EDSS change +1 point among those with EDSS ≥2.5 over minimum 3 years of follow up
- Change in MSIS-29 over minimum 3 years of follow up (change from baseline; mean value ±SD)
RTX = rituximab
DMF = dimethylfumarat
GA = glatirameracetat
IFN = interferon beta
NTZ = natalizumab
FGL = fingolimod
Time line for the study
Photo: Anna Fogdell-Hahn