Efficacy and Safety of Ocrelizumab in PPMS Study

This document is a late-breaking abstract presented at the 41st Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) on September 26, 2025. It details the results of the Phase IIIb ORATORIO-HAND study, which evaluates the efficacy and safety of ocrelizumab compared to placebo in patients with primary progressive multiple sclerosis (PPMS). The study aims to assess the impact of ocrelizumab on older patients and those with more advanced disease, particularly concerning hand function and overall disability progression. The document outlines the inclusion and exclusion criteria for participants, emphasizing the broader eligibility for the ORATORIO-HAND study compared to the earlier ORATORIO trial. It also describes the study design, which is event-driven, double-blind, and placebo-controlled, detailing the treatment regimen and primary and secondary endpoints. The findings are significant for understanding the treatment's effects on this patient population.