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

Last updated: December 23, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Ofatumumab

Clinical Study ID

NCT06486779
COMB157GGR01
  • Ages 18-55
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Written IC must be obtained before participating in the study.

  2. Patients with diagnosis of RMS per McDonald Criteria (2017) and <5 years since firstMS symptom prior to initiation of ofatumumab.

  3. Patients who have been on treatment with ofatumumab for at least 3 months, but notlonger than 6 months prior to inclusion in the study.

  4. Ofatumumab treatment in line with the European Product Information of Kesimpta (i.e., adult patients with relapsing forms of MS with active disease defined byclinical or imaging features).

  5. Patients with at least one available brain MRI scan performed at least 3 monthsafter ofatumumab initiation OR for whom the physician (as per her/his routinepractice and independently of his/her decision to include the patient in the currentstudy) plans to perform such scanning within 31 days after patient's inclusion inthe study. Notes: This MRI scan can be either brain gadolinium enhanced (Gd+) or not. In caseit is not gadolinium enhanced, the most recent MRI prior to ofatumumab treatmentshould be brain gadolinium enhanced, for relevant comparison and identification ofnew lesions. This MRI scan will serve as the index reference assessment for theevaluation of NEDA-3 radiological component and shall not have been performed within 30 days after the termination of steroid therapy.

  6. Patients willing and able to complete the assessments, including PRO questionnaires,as per physicians' clinical practice and as outlined in this study.

Exclusion

Exclusion Criteria:

  1. Use of investigational drugs during the study, OR between ofatumumab initiation andinclusion into the study, OR within 3 months before ofatumumab initiation, OR within 5 half-lives of investigational drug before ofatumumab initiation, OR until theexpected pharmacodynamic effect has returned to baseline, whichever is longer.

  2. Currently pregnant (or intention to become pregnant within the study period),breastfeeding or lactating women.

Study Design

Total Participants: 160
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase:
Study Start date:
December 10, 2024
Estimated Completion Date:
December 30, 2028

Study 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.

Connect with a study center

  • Novartis Investigative Site

    Chaidari, Attiki 12462
    Greece

    Site Not Available

  • Novartis Investigative Site

    Ioannina, Epirus 455 00
    Greece

    Site Not Available

  • Novartis Investigative Site

    Alexandroupolis, Evros 681 00
    Greece

    Site Not Available

  • Novartis Investigative Site

    Athens, GR 115 27
    Greece

    Site Not Available

  • Novartis Investigative Site

    Patras, Peloponissos 265 00
    Greece

    Site Not Available

  • Novartis Investigative Site

    Larissa, Thessalia 411 10
    Greece

    Site Not Available

  • Novartis Investigative Site

    Alexandroupoli 736928, 681 00
    Greece

    Active - Recruiting

  • Novartis Investigative Site

    Athens 264371, 115 21
    Greece

    Active - Recruiting

  • Novartis Investigative Site

    Chaïdári 260183, 124 62
    Greece

    Active - Recruiting

  • Novartis Investigative Site

    Crete Heraklion, 714 09
    Greece

    Active - Recruiting

  • Novartis Investigative Site

    Greece, 53246
    Greece

    Site Not Available

  • Novartis Investigative Site

    Ioannina 261779, 455 00
    Greece

    Active - Recruiting

  • Novartis Investigative Site

    Larissa 258576, 411 10
    Greece

    Active - Recruiting

  • Novartis Investigative Site

    Pátrai 255683, 265 04
    Greece

    Active - Recruiting

  • Novartis Investigative Site

    Thessaloniki, GR 54636
    Greece

    Site Not Available

  • Novartis Investigative Site

    Thessaloniki 734077, 53246
    Greece

    Active - Recruiting

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