COMBAT-MS core.

Aim 1: First line RTX vs DMF/GA/IFN

  1. Proportion of patients EDSS ≤2.5 to 6 months confirmed EDSS ≥3 over minimum 3 years of follow up
  2. Proportion of patients with 6 months confirmed EDSS change +1 point among those with EDSS ≥2.5 over minimum 3 years of follow up
  3. 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

  1. Proportion of patients EDSS ≤2.5 to 6 months confirmed EDSS ≥3 over minimum 3 years of follow up
  2. Proportion of patients with 6 months confirmed EDSS change +1 point among those with EDSS ≥2.5 over minimum 3 years of follow up
  3. 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

  1. Proportion of patients EDSS ≤2.5 to 6 months confirmed EDSS ≥3 over minimum 3 years of follow up
  2. Proportion of patients with 6 months confirmed EDSS change +1 point among those with EDSS ≥2.5 over minimum 3 years of follow up
  3. 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
Time line for the study Photo: Anna Fogdell-Hahn
15-03-2024