Observational Study of Ofatumumab in Patients with Relapsing Multiple Sclerosis Comparing Early and Late Treatment Start in Portugal

What this Trial Is About

Researchers are evaluating the effectiveness of Ofatumumab treatment in patients with relapsing multiple sclerosis (RMS) in Portugal. The study compares patients who started Ofatumumab within three years of their RMS diagnosis to those who began treatment more than three years after diagnosis. This observational study reflects real-world medical care and aims to understand how timing of treatment initiation might impact disease activity. The study includes two groups of patients based on when they started Ofatumumab: early initiators and later initiators. Ofatumumab is prescribed by physicians according to local guidelines, and no medication is provided by the study sponsor. Data will be collected during three visits over a maximum of 24 months. If a patient's disability worsens at the 12- or 24-month visits, an additional follow-up visit will be conducted 6plus or minus 1 month later to confirm this change. Participants will undergo assessments including patient-reported outcome questionnaires and disability status evaluations. The main outcome measured is the proportion of patients showing no evidence of disease activity (NEDA-3) from month 12 to month 24. The study requires patients to have been treated with Ofatumumab for at least two years. The total participation period may extend up to 24 months, with additional visits if disability progression is suspected.

Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study