Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
NCT ID: NCT05809986
Last Updated: 2025-01-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
174 participants
OBSERVATIONAL
2023-11-27
2026-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cohort 1: Early treatment arm
All patients who initiated Ofatumumab within 3 years after MS diagnosis (can be treatment-naive or switch).
Ofatumumab
There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Cohort 2: Late treatment arm
All patients who initiated Ofatumumab with more than 3 years of MS diagnosis.
Ofatumumab
There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Interventions
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Ofatumumab
There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Use of high efficacy therapy (including Ocrelizumab, Natalizumab, Mitoxantrone, Rituximab and Alemtuzumab) in both cohorts prior to the initiation of Ofatumumab.
18 Years
99 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Amadora, , Portugal
Novartis Investigative Site
Guimarães, , Portugal
Novartis Investigative Site
Leiria, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Lisbon, , Portugal
Novartis Investigative Site
Matosinhos Municipality, , Portugal
Novartis Investigative Site
Ponte de Lima, , Portugal
Novartis Investigative Site
Porto, , Portugal
Novartis Investigative Site
Setúbal, , Portugal
Countries
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Central Contacts
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Novartis Pharmaceuticals
Role: CONTACT
Other Identifiers
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COMB157GPT04
Identifier Type: -
Identifier Source: org_study_id
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