For Healthcare Professionals

Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION CRITERIA

Inclusion Criteria:


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


  1. Patients aged 18 years or older
  2. Written informed consent obtained before participating in the study.
  3. Patient is willing and able to complete the assessments, including PRO questionnaires, as outlined in this study.
  4. Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
  5. Treatment with Ofatumumab is in accordance with the Portuguese indication of Kesimpta® (i.e., treatment of adult patients with relapsing multiple sclerosis (RMS) with active disease defined by clinical or imaging features).
  6. Patients that have initiated Ofatumumab up to 12 M prior inclusion in the study OR Patients that are initiating Ofatumumab at the moment of study inclusion.

EXCLUSION CRITERIA

Exclusion Criteria:


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


  1. Use of investigational drugs during the study, OR between Ofatumumab initiation and inclusion into the study, OR within 5 half-lives of investigational drug before Ofatumumab initiation, OR until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
  2. Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall +41613241111Email iconEmail Study Center

Study Details


Contition

Relapsing Multiple Sclerosis

Age

18+

Participants Needed

174

Est. Completion Date

Sep 15, 2026

Treatment Type

OBSERVATIONAL


Sponsor

Novartis

ClinicalTrials.gov NCT Identifier

NCT05809986

Study Number

COMB157GPT04

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