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Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

Recruitingn/aAges 18 Years - 99 YearsAllNovartis Pharmaceuticals
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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: 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.
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What it tests

  • Ofatumumab
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Where

10 sites
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

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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