Observational study of ofatumumab in Greek adults with relapsing multiple sclerosis
Studies ofatumumab in adults with relapsing multiple sclerosis receiving routine care in Greece.
Plain-language title generated from the registry record
Registry title: Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study
Key facts
- Where
- Alexandroupoli, Athens, Chaïdári, Crete Heraklion, Ioannina, Larissa, Pátrai, and Thessaloniki, GreeceSee the 8 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 55 years old?
Source: NCT06486779, who can take part
Where in Greece
- AlexandroupoliAlexandroupoli, GreeceTaking people
- AthensAthens, GreeceTaking people
- ChaïdáriChaïdári, GreeceTaking people
- Crete HeraklionCrete Heraklion, GreeceTaking people
- IoanninaIoannina, GreeceTaking people
- LarissaLarissa, GreeceTaking people
- PátraiPátrai, GreeceTaking people
- ThessalonikiThessaloniki, GreeceTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharmaceuticals
- Trial code
- NCT06486779
- Record updated
- 11 June 2026
- Original description
This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)Read full original descriptionShow less
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)
This study is a single-country, non-interventional, multicenter, observational study, mainly based on primary data collection to assess the effect of ofatumumab on clinical parameters of Multiple Sclerosis (MS) in a routine medical care setting, as compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS, which includes glatiramer acetate, interferons, teriflunomide, or dimethyl fumarate)
Inclusion: Written IC must be obtained before participating in the study; Patients with diagnosis of RMS per McDonald Criteria (2017) and <5 years since first MS symptom prior to initiation of ofatumumab; 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; 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); 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; Patients willing and able to complete the assessments, including PRO questionnaires, as per physicians' clinical practice and as outlined in this study.
Exclusion: 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; Currently pregnant (or intention to become pregnant within the study period), breastfeeding or lactating women.