Actively Recruiting

Age: 18Years - 55Years
All Genders
NCT06486779

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

Led by Novartis Pharmaceuticals · Updated on 2025-12-24

160

Participants Needed

14

Research Sites

211 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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)

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Written informed consent must be obtained before participating in the study.
  • Diagnosis of Relapsing Multiple Sclerosis (RMS) according to McDonald Criteria (2017).
  • Less than 5 years since the first MS symptom before starting ofatumumab.
  • Treatment with ofatumumab for at least 3 months but not longer than 6 months before study inclusion.
  • Ofatumumab treatment aligned with European Product Information for Kesimpta.
  • At least one brain MRI scan performed at least 3 months after starting ofatumumab or planned within 31 days after study inclusion.
  • Willingness and ability to complete study assessments, including patient-reported outcome questionnaires.
Not Eligible

You will not qualify if you...

  • Use of investigational drugs during the study, or within specified time frames before starting ofatumumab.
  • Currently pregnant, breastfeeding, or intending to become pregnant during the study period.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 14 locations

1

Novartis Investigative Site

Alexandroupoli, Greece, 681 00

Actively Recruiting

2

Novartis Investigative Site

Athens, Greece, 115 21

Actively Recruiting

3

Novartis Investigative Site

Athens, Greece, 115 25

Actively Recruiting

4

Novartis Investigative Site

Athens, Greece, 115 27

Actively Recruiting

5

Novartis Investigative Site

Athens, Greece, 115 28

Actively Recruiting

6

Novartis Investigative Site

Athens, Greece, 145 61

Active, Not Recruiting

7

Novartis Investigative Site

Athens, Greece, 185 47

Actively Recruiting

8

Novartis Investigative Site

Chaïdári, Greece, 124 62

Actively Recruiting

9

Novartis Investigative Site

Crete Heraklion, Greece, 714 09

Actively Recruiting

10

Novartis Investigative Site

Ioannina, Greece, 455 00

Actively Recruiting

11

Novartis Investigative Site

Larissa, Greece, 411 10

Actively Recruiting

12

Novartis Investigative Site

Pátrai, Greece, 265 04

Actively Recruiting

13

Novartis Investigative Site

Thessaloniki, Greece, 53246

Actively Recruiting

14

Novartis Investigative Site

Thessaloniki, Greece, GR 54636

Actively Recruiting

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Research Team

N

Novartis Pharmaceuticals

CONTACT

N

Novartis Pharmaceuticals

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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