Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

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

Phase

N/A

Condition

Neurologic Disorders

Memory Loss

Multiple Sclerosis

Treatment

Ofatumumab

Clinical Study ID

NCT05809986
COMB157GPT04
  • Ages 18-99
  • All Genders

Study Summary

This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.

Eligibility Criteria

Inclusion

Inclusion Criteria:

To participate in the study, all the following inclusion criteria must be met:

  • Patients aged 18 years or older

  • Written informed consent obtained before participating in the study.

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

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

  • Treatment with Ofatumumab is in accordance with the Portuguese indication ofKesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS)with active disease defined by clinical or imaging features).

  • Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study ORPatients that are initiating Ofatumumab at the moment of study inclusion.

Exclusion

Exclusion Criteria:

To participate in the study, none of the following exclusion criteria must be met:

  • 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.

  • Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone,Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.

Study Design

Total Participants: 174
Treatment Group(s): 1
Primary Treatment: Ofatumumab
Phase:
Study Start date:
November 27, 2023
Estimated Completion Date:
September 15, 2026

Study Description

This is a 2 cohort, multi-center, observational study carried out in Portugal that aims to describe the effectiveness of Ofatumumab in a setting of routine medical care. Primary data will be collected from Multiple Sclerosis patients who initiate Ofatumumab early and later in their disease (cohorts 1 and 2, respectively).

Data will be collected during 3 visits distributed over a maximum period of 24 months. Exceptionally, if the patient shows Expanded Disability Status Scale (EDSS) worsening in visit 2 or 3 (12 and 24 months after Ofatumumab initiation, respectively), there will be an additional visit 6±1 months after visit 2 or 3 for EDSS confirmation.

The study includes patients that have initiated Ofatumumab up to 12 months prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.

Patients in both cohorts will have to be treated with Ofatumumab for at least two years to compare No Evidence of Disease Activity (NEDA)-3 at 12 to 24 months, respectively.

Connect with a study center

  • Novartis Investigative Site

    Amadora, 2720-276
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Guimaraes, 4835-044
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Leiria, 2410-104
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Lisboa, 1349-019
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Matosinhos, 4454 513
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Ponte de Lima, 4990 041
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Porto, 4200 319
    Portugal

    Active - Recruiting

  • Novartis Investigative Site

    Setubal, 2910-446
    Portugal

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.