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Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

NCT05809986

RecruitingN/A

Sponsor: Novartis Pharmaceuticals

Conditions: Relapsing Multiple Sclerosis

Interventions: Ofatumumab

Countries: Portugal

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 overview

Sex: ALL

Age: 18 Years to 99 Years

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility 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:

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.
Locations (10)
  • Amadora, Portugal
  • Guimarães, Portugal
  • Leiria, Portugal
  • Lisbon, Portugal
  • Lisbon, Portugal
  • Lisbon, Portugal
  • Matosinhos Municipality, Portugal
  • Ponte de Lima, Portugal
  • Porto, Portugal
  • Setúbal, Portugal