Kesimpta (Ofatumumab) in Greek Multiple Sclerosis Patients - an Observational Study

Recruiting now

Conditions studied: Relapsing Multiple Sclerosis (RMS)

In brief

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)

Key facts

Study ID

NCT06486779

Run by

Novartis Pharmaceuticals

People needed

160

Starts

2024-12-10

Expected to finish

2028-12-30

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 55. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Novartis Investigative Site — Thessaloniki, Greece (enrolling)
• Novartis Investigative Site — Athens, GR, Greece (enrolling)
• Novartis Investigative Site — Alexandroupoli, Greece (enrolling)
• Novartis Investigative Site — Athens, Greece (enrolling)
• Novartis Investigative Site — Athens, Greece (enrolling)
• Novartis Investigative Site — Athens, Greece (enrolling)
• Novartis Investigative Site — Athens, Attica, Greece (enrolling)
• Novartis Investigative Site — Athens, Greece (enrolling)
• Novartis Investigative Site — Chaïdári, Greece (enrolling)
• Novartis Investigative Site — Crete Heraklion, Greece (enrolling)
• Novartis Investigative Site — Ioannina, Greece (enrolling)
• Novartis Investigative Site — Larissa, Greece (enrolling)
• Novartis Investigative Site — Pátrai, Greece (enrolling)
• Novartis Investigative Site — Thessaloniki, Greece (enrolling)
• Novartis Investigative Site — Athens, Greece

Full record on ClinicalTrials.gov

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