Observing people with relapsing MS who start approved injectable or selected oral disease-modifying treatments

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This non-interventional, multicenter, open-label observational program collects prospective primary data from adults with relapsing MS who begin approved injectable or selected oral disease-modifying therapies. Information is gathered via questionnaires and an electronic case report form, plus medical history, EDSS, MRI parameters, laboratory values, and relapse records, over up to four years (core 2 years with an optional 2-year extension). Treatment decisions must be made by the treating physician and patient before enrollment and routine diagnostic or monitoring procedures follow standard clinical care; visit timing is per investigator discretion and may include telemedicine. Participating sites are Novartis investigative centers in Baden-Württemberg, Germany.

Why it matters

Who can join: the full rules

Cohort 1 Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation in the study
2. Male or female patients aged ≥18 years at enrollment
3. Diagnosis of MS according to the 2017 revised McDonald criteria (Thompson et al 2018b)
4. RMS with active disease as defined by Lublin et al. (2014)
5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment
6. Disability status at enrollment with an EDSS score of 0 to 2.5 (inclusive)
7. Planned initiation or initiation within the past 14 days with an approved injectable DMT for MS as routine medical treatment

Cohort 2 Inclusion Criteria:

1. Signed informed consent must be obtained prior to participation,
2. Male or female patients aged ≥18 years at enrollment,
3. Diagnosis of MS according to the 2024 revised McDonald criteria (Montalban et al., 2025),
4. RMS with active disease as defined by Lublin et al. (2014) ,
5. Max. 1 relapse during the previous year and max. 2 relapses during the previous two years prior to enrollment,
6. Disability status at enrollment with an EDSS score of 0 to 3.0 (inclusive),
7. 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:

1. Patients being treated outside of the approved label
2. \> 5 years since first symptom(s) (leading to MS diagnosis) at enrollment
3. 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)
4. 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
5. Poor recovery from the first two relapses prior to enrollment upon discretion of the investigator
6. EDSS Functional System Score "Pyramidal Functions" ≥ 2 at enrollment
7. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab

Cohort 2 Exclusion Criteria:

1. Patients being treated outside of the approved label,
2. \>5 years since first symptom(s) (leading to MS diagnosis) at enrollment,
3. Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with Ofatumumab,
4. Patients being previously enrolled in cohort 1 are not eligible to be enrolled into cohort 2

Where it's running

• Novartis Investigative Site
  Albstadt, Baden-Wurttemberg, Germany Recruiting
• Novartis Investigative Site
  Hettingen, Baden-Wurttemberg, Germany Recruiting
• Novartis Investigative Site
  Mannheim, Baden-Wurttemberg, Germany Recruiting
• Novartis Investigative Site
  Nagold, Baden-Wurttemberg, Germany Recruiting
• Novartis Investigative Site
  Schwäbisch Hall, Baden-Wurttemberg, Germany Recruiting
• Novartis Investigative Site
  Schwetzingen, Baden-Wurttemberg, Germany Recruiting

+91 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Novartis Pharmaceuticals
• Email: novartis.email@novartis.com
• Phone: +41613241111

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Observing the effects of Ofatumumab in Portuguese patients with relapsing multiple sclerosis

  This study is testing how well Ofatumumab works for Portuguese patients with relapsing multiple sclerosis who started treatment either within three years of their diagnosis or after, to see if it helps them stay symptom-free.

  Recruiting at 10 sites Novartis · Amadora and 9 other locations · NCT05809986

• Ofatumumab for drug-refractory Narcolepsy Type 1

  Aims to see if a single dose of ofatumumab helps people with Narcolepsy Type 1 who have not responded to previous treatments.

  Recruiting Phase 1/2 Xijing Hospital · Xi'an, Shaanxi · NCT07871006

• Comparing Ofatumumab vs Ocrelizumab in Real-World MS Care

  This real-world study tests whether ofatumumab works differently from ocrelizumab for people with multiple sclerosis.

  Recruiting Novartis · East Hanover, New Jersey · NCT07779460

• Switching to Ofatumumab: IgG Levels in People with MS

  A real-life study tests whether stopping ocrelizumab and starting ofatumumab changes IgG levels in adults with multiple sclerosis who have been on ocrelizumab for at least 18 months.

  Recruiting University Hospital, Lille · Lille · NCT07625800

• Ofatumumab treatment and blood neurofilament levels in relapsing multiple sclerosis

  This observational study will try ofatumumab in adults with relapsing MS to see if it is safe and whether blood neurofilament light chain (sNfL) levels change.

  Recruiting Third Affiliated Hospital, Sun Yat-Sen University · Guangzhou, Guangdong · NCT07353216

• Ublituximab in Pediatric Relapsing MS: See if a B-cell therapy works in kids

  This study tests whether ublituximab can work in children and teens with relapsing MS and compares it to fingolimod in eligible participants.

  Recruiting at 5 sites Phase 2/3 TG Therapeutics, Inc. · Salt Lake City, Utah and 5 other locations · NCT07220252

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.