NCT06486779

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

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)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

Primary data from MS adult patients who initiate ofatumumab early in their disease course will be collected over a period of two years, and will be compared to the ofatumumab and Standard of Care (SoC) arms of the STHENOS trial, a closely monitored phase-IIIb trial. Eligible patients are those with Relapsing Multiple Sclerosis (RMS) diagnosis, with 1st MS symptom within 5 years prior to ofatumumab's initiation and on treatment with ofatumumab for at least 3 months, but not longer than 6 months prior to inclusion in the study. The overall study duration is expected to be 48 months, including a recruitment period and a per-patient observation period of 24 months each. Follow-up visit frequency will be determined by the treating physician, however study-related data will be collected at study enrollment and at 6-, 12-, 18-, and 24-month data collection timepoints post with an allowable time window of ±1 month for all data collection timepoints. NEDA-3 status, MS Relapse, EDSS, MRI, PROs questionnaires, MSIS-29, SDMT, Adherence and persistence, AEs will be assessed during the study.

Conditions

• Relapsing Multiple Sclerosis (RMS)

Interventions

Type	Name	Description
OTHER	Ofatumumab	This is an observational study. There is no treatment allocation. The decision to initiate ofatumumab will be based solely on clinical judgement.

Timeline

• Start date: 2024-12-10
• Primary completion: 2028-12-30
• Completion: 2028-12-30
• First posted: 2024-07-05
• Last updated: 2025-12-24

Locations

14 sites across 1 country: Greece