A NIS Evaluating Various Injectable and Oral Treatments in Patients With Relapsing Multiple Sclerosis

Criteria the registry did not label

• Cohort 1 Inclusion Criteria:
• Signed informed consent must be obtained prior to participation in the study
• Male or female patients aged ≥18 years at enrollment
• Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
• RMS with active disease as defined by Lublin et al. (2014)
• Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
• Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
• Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment
  • Cohort 2 Inclusion Criteria:
• Signed informed consent must be obtained prior to participation,
• Male or female patients aged ≥18 years at enrollment,
• Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),
• RMS with active disease as defined by Lublin et al. (2014) ,
• Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment,
• Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive),
• Planned initiation or initiation within the past 14 days with an approved injectable or oral DMT for MS as routine medical treatment:
  • Ofatumumab: only naïve patients or patients previously treated with max. one DMT other than ofatumumab
  • IFN-β1, GA, teriflunomide, DMF or DRF: only naïve patients
  • Cohort 1 Exclusion Criteria:
• Patients being treated outside of the approved label
• \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
• Previous therapy with any DMT for the treatment of MS prior to enrollment (except within the past 14 days with an approved injectable DMT for MS as routine medical treatment; see Inclusion criteria #7)
• Relapse prior to enrollment which has led to a severe deficit relevant to everyday life upon discretion of the investigator after exhaustion of the relapse therapy
• Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
• EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
• Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab
  • Cohort 2 Exclusion Criteria:
• Patients being treated outside of the approved label,
• \>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,
• Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,
• Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2