Early Versus Late Ofatumumab (Kesimpta®) Use in Austrian RMS-Patients Over 2 Years

Last updated: January 12, 2025
Sponsor: Novartis Pharmaceuticals
Overall Status: Active - Recruiting

Phase

N/A

Condition

Multiple Sclerosis

Memory Loss

Scar Tissue

Treatment

Ofatumumab

Clinical Study ID

NCT05776888
COMB157GAT02
  • Ages 18-99
  • All Genders

Study Summary

This non-interventional study aims to observe the effect of early versus late Ofatumumab treatment in RMS patients in a real-world setting in Austria over an observational period of 24 months.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patients with relapsing multiple sclerosis (RMS) with disease activity defined byclinical assessment or MRI analysis.

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

  3. Patient is willing and able to complete the assessments, as outlined in this study.

  4. Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation ofOfatumumab.

  5. Patients in both cohorts must have been on treatment with Ofatumumab for at least 3months, but not longer than 12 months prior to inclusion in the study.

  6. Cohort 1: Patients that, before initiation of Ofatumumab, were either treatmentnaive or have started their treatment for RMS with another disease modifying therapy (BRACE, teriflunomide or fumarates). Non-naive patients in this cohort must havestarted the use of Ofatumumab within 3 years after first DMT initiation.

  7. Cohort 2: Patients must have been on either BRACE or Teriflunomide or fumarates forat least three years or longer before the switch to Ofatumumab has been initiated.Thus, this cohort includes patients that use Ofatumumab as second or later line DMT.

Exclusion

Exclusion Criteria:

  1. Patients who have been on Ofatumumab less than 3 months or more than 12 monthsbefore inclusion.

  2. Use of investigational drugs during the study, OR between Ofatumumab initiation andinclusion into the study, OR within 5 half-lives of investigational drug beforeOfatumumab initiation, OR until the expected pharmacodynamic effect has returned tobaseline, whichever is longer.

  3. Use of any high efficacy therapy (including Fingolimod, Siponimod, Ponesimod,Ozanimod, Rituximab, Ocrelizumab, Natalizumab, Alemtuzumab, Mitoxantron orCladribine) in either cohort prior to the initiation of Ofatumumab.

  4. Previous use of any DMTs other than BRACE, Teriflunomide or fumarates prior to theinitiation of Ofatumumab.

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase:
Study Start date:
July 10, 2023
Estimated Completion Date:
August 31, 2026

Study Description

This multi-center, observational study will describe the effects of Ofatumumab in 2 cohorts in a routine medical care setting. Cohort one will comprise patients who have started Ofatumumab early during their disease (treatment naive patients or those that started Ofatumumab within 3 years of first therapy initiation). Cohort two will include patients who have been on other DMTs (one or several) for a minimum of 3 years prior to switching to Ofatumumab. Patients in both cohorts will be observed for two years.

Connect with a study center

  • Novartis Investigative Site

    Mistelbach, 2130
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Vienna, A 1090
    Austria

    Active - Recruiting

  • Novartis Investigative Site

    Wels, 4600
    Austria

    Site Not Available

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