RecruitingNCT05809986

Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study

Sponsor

Novartis Pharmaceuticals

Enrollment

174 participants

Start Date

Nov 27, 2023

Study Type

OBSERVATIONAL

Conditions

Relapsing Multiple Sclerosis

Summary

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

Min Age: 18 YearsMax Age: 99 Years

Inclusion Criteria6

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 Criteria2

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.

Interventions

OTHEROfatumumab

There is no treatment allocation. Ofatumumab will be prescribed by the physician as per locally approved label. No drug will be dispensed from Novartis