Observing the effects of Ofatumumab on Multiple Sclerosis in Greece

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 observational study aims to assess the impact of Ofatumumab on clinical parameters in patients with Relapsing Multiple Sclerosis (RMS) in Greece. It will collect primary data from adult patients who have started Ofatumumab treatment within the last 6 months and will follow them for two years. The data collected will be compared to the standard of care from a closely monitored phase-IIIb trial. Key assessments will include NEDA-3 status, MS relapses, EDSS scores, MRI results, and patient-reported outcomes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written IC must be obtained before participating in the study.
2. Patients with diagnosis of RMS per McDonald Criteria (2017) and \<5 years since first MS symptom prior to initiation of ofatumumab.
3. Patients who have been on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study.
4. Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined by clinical or imaging features).
5. Patients with at least one available brain MRI scan performed at least 3 months after ofatumumab initiation OR for whom the physician (as per her/his routine practice and independently of his/her decision to include the patient in the current study) plans to perform such scanning within 31 days after patient's inclusion in the study.

   Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In case it is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatment should be brain gadolinium enhanced, for relevant comparison and identification of new lesions. This MRI scan will serve as the index reference assessment for the evaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy.
6. Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.

Exclusion Criteria:

1. Use of investigational drugs during the study, OR between ofatumumab initiation and inclusion into the study, OR within 3 months before ofatumumab initiation, OR within 5 half-lives of investigational drug before ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
2. Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.

Where it's running

• Novartis Investigative Site
  Athens, Attica, Greece Recruiting
• Novartis Investigative Site
  Athens, Gr, Greece Recruiting
• Novartis Investigative Site
  Alexandroupoli, Greece Recruiting
• Novartis Investigative Site
  Athens, Greece Recruiting
• Novartis Investigative Site
  Athens, Greece Recruiting
• Novartis Investigative Site
  Athens, Greece Recruiting

Study contacts

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

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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.