Study Description
This is a non-interventional, cross-sectional, multicentric, and nationwide study, based
on primary and secondary data collection. The present study aims to characterize the use of subcutaneous ofatumumab in a real-world
setting. Specifically, the investigation will assess the effectiveness, safety, and
treatment adherence associated with subcutaneous ofatumumab in individuals with relapsing
forms of multiple sclerosis (RMS) within the Spanish healthcare system.
The study will use primary and secondary data collection. Primary data collection
includes information collected using PRO, clinical-reported outcomes (ClinRO), scales or
tests and the interview during the study visit. Secondary data collection includes
existing data from electronic medical records (EMR) or paper-based medical records,
collected as part of the routine follow-up of patients with RMS in the clinical practice.
Baseline will be defined as the date of ofatumumab initiation.
Interventions
ofatumumab
Eligibility Criteria
Inclusion Criteria:
1. Aged ≥ 18 years.
2. Written informed consent.
3. Diagnosis of RMS per McDonald Criteria (2017).
4. Ofatumumab treatment in line with the European Kesimpta® summary of product
characteristics (SmPC; i.e. adult patients with RMS with active disease defined by
clinical or imaging features) during at least 12 months and patients who
discontinued ofatumumab after receiving at least one dose with a minimum monitoring
of 12 months.
Exclusion Criteria:
1. Currently participating in a clinical trial.
2. Not able/unlikely to complete with all study activities according to investigator's
criteria.
3. Have a contraindication for ofatumumab use, according to the SmPC.
Worldwide Contacts
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