RecruitingNCT06486779

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)


Sponsor

Novartis Pharmaceuticals

Enrollment

160 participants

Start Date

Dec 10, 2024

Study Type

OBSERVATIONAL

Conditions

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)


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This observational study is tracking real-world outcomes for people in Greece with relapsing multiple sclerosis (MS) who have recently started a drug called ofatumumab (Kesimpta), with a focus on brain MRI changes and clinical improvements over time. **You may be eligible if...** - You have been diagnosed with relapsing multiple sclerosis per established criteria - You had your first MS symptoms less than 5 years ago - You have been taking ofatumumab for at least 3 months but no more than 6 months before joining the study - You have had a brain MRI at least 3 months after starting ofatumumab, or your doctor plans to perform one **You may NOT be eligible if...** - You have been on ofatumumab for less than 3 months or more than 6 months - You are unable to provide written informed consent - You do not meet the product labeling requirements for ofatumumab use Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHEROfatumumab

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


Locations(14)

Novartis Investigative Site

Alexandroupoli, Greece

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Athens, Greece

Novartis Investigative Site

Chaïdári, Greece

Novartis Investigative Site

Crete Heraklion, Greece

Novartis Investigative Site

Ioannina, Greece

Novartis Investigative Site

Larissa, Greece

Novartis Investigative Site

Pátrai, Greece

Novartis Investigative Site

Thessaloniki, Greece

Novartis Investigative Site

Thessaloniki, Greece

View Full Details on ClinicalTrials.gov

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NCT06486779