Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
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.
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:
- 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 PRO questionnaires, as outlined in this study.
- Diagnosis of RMS per McDonald Criteria (2017) occurred prior to initiation of Ofatumumab.
- 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).
- 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:
- 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.
- Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.
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.
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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