Home › Trials › NCT06486779

Observing the effects of Ofatumumab on Multiple Sclerosis in Greece

A Non-interventional multiCenter Observational Study to Evaluate tHe Effectiveness and Patient-Reported Outcomes of Ofatumumab (Kesimpta®) in patieNts With Relapsing Multiple sclerOsis Treated in Routine Care Settings in Greece (CHRONOS)

Observational Novartis · NCT06486779

This study is trying to see how well Ofatumumab works for adults with Relapsing Multiple Sclerosis in Greece over two years.

Quick facts

Study typeObservational
Enrollment160 (estimated)
Ages18 Years to 55 Years
SexAll
SponsorNovartis Industry-sponsored
Drugs / interventionsofatumumab
Locations14 sites (Alexandroupoli and 13 other locations)
Trial IDNCT06486779 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults diagnosed with RMS within the last 5 years who have recently started Ofatumumab treatment.

Not a fit: Patients who have been on Ofatumumab for more than 6 months prior to study inclusion may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide insights into the effectiveness of Ofatumumab compared to standard treatments for RMS.

How similar studies have performed: Other studies have shown success with similar observational approaches, but this specific study focuses on a novel population and treatment context.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Alexandroupoli and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Relapsing Multiple SclerosisRMSNISGreeceOfatumumabKesimpta
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.