Comparative Study of High-Efficacy Disease Modifying Treatment of Relapsing Multiple Sclerosis
The goal of this prospective, multi-center, non-blinded, non-randomized, non-intervention clinical trial is to compare immunologic, virologic and epigenetic factors in patients with active multiple sclerosis in standard 2.line treatment with ocrelizumab, rituximab, ofatumumab or natalizumab in Region Midt, Denmark. It aims to answer how the immunologic, virologic and epigenetic response in these patients are compared to healthy controls, and analyze their treatment effect in relation to this response. Participants will get an extra blood sample, when they have their routine blood samples taken.
• Multiple sclerosis diagnosis and definition of disease course according to the 2017 McDonald criteria
• Expanded disability status scale (EDSS) ≤6.5
• Signed written informed consent
• Fulfilling criteria for active MS: Treatment naïve relapsing remitting multiple sclerosis (RRMS) patients (never treated, or no DMT the previous 2 years):
‣ 2 relapse previous 12 months OR
‣ 1 relapse previous 12 months with severe residual symptoms and EDSS ≥ 3.0 OR
‣ 1 relapse previous 12 months AND ≥9 T2 lesions on brain and/or spinal cord MRI AND
∙ contrast-enhancing lesion or ≥1 new or enlarging T2 lesion on brain and/or spinal cord MRI previous 12 month
• Previously treated RRMS patients:
⁃ 1 relapse previous 12 months OR
⁃ 1 contrast-enhancing lesion or ≥2 new/enlarging T2 lesions on brain and/or spinal cord MRI previous 12 months