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

Last updated: January 11, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Neurologic Disorders

Treatment

Ofatumumab

Clinical Study ID

NCT05285904
COMB157GCH01
  • Ages 18-99
  • All Genders

Study Summary

This is a multi-center, observational study carried out in Switzerland that aims to describe the effects of Ofatumumab in a setting of routine medical care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Written informed consent must be obtained before participating in the study.

  2. Diagnosis of RMS per McDonald Criteria (2017) occurred within 3 years prior toinitiation of Ofatumumab.

  3. Adult patients who have been on treatment with Ofatumumab for at least 3 months, butnot longer than 12 months prior to inclusion in the study.

  4. Ofatumumab treatment in line with the Swiss Kesimpta® label (i.e. adult patientswith active, relapsing forms of MS)

  5. Patient is willing and able to complete patient diary during course of the study, aswell as to complete PRO questionnaires.

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. Subjects who are not able to provide consent due to incapable judgement

Study Design

Total Participants: 149
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase:
Study Start date:
May 12, 2022
Estimated Completion Date:
June 30, 2026

Study Description

This non-interventional study will observe the effect of Ofatumumab treatment compared to the standard of care (SoC) arm of a closely monitored phase-IIIb study (STHENOS-COMB157G3301) in MS patients in a real-world setting in Switzerland over an observational period of 12 month.

Connect with a study center

  • Novartis Investigative Site

    Baden, Aargau 5405
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Liestal, BL 4410
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Chur, GR 7000
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Luzern, LU 6006
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Wil, SG 9500
    Switzerland

    Site Not Available

  • Novartis Investigative Site

    Sargans, Saint Gallen 7320
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Gland, Vaud 1196
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Zug, ZG 6300
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Zurich, ZH 8006
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Basel, 4001
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Bern, 3010
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Lausanne, 1011
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Lugano, 6900
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Sion, 1950
    Switzerland

    Active - Recruiting

  • Novartis Investigative Site

    Zuerich, 8091
    Switzerland

    Active - Recruiting

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