Study to Assess the Effect of Ofatumumab in Treatment Naïve, Very Early RRMS Patients Benchmarked Against Healthy Controls.

The study is an open-label, multi-center, prospective 18-month study in 119 MS participants with early RRMS (defined as within 6 months of diagnosis of clinically definite RRMS) and who are treatment naïve. It is designed to determine if RRMS participants treated with 20 mg subcutaneous monthly ofatumumab during the earliest part of their disease will benefit from the use of ofatumumab as their first disease modifying therapy. Additionally, RRMS patients will be compared to age- and sex-matched healthy participants (n=61) for select outcomes to observe similarities and differences between the groups. After giving consent, participants have a 28-day screening/qualification period. If they qualify to continue, they start study measures including assessments of clinical and magnetic resonance imaging (MRI) metrics and use of a digital monitoring watch. Additionally, samples are collected for laboratory and biomarker analysis. RRMS participants begin treatment with ofatumumab for the next 18 months. Healthy participants undergo similar assessments; however they do not receive any treatment during the course of the study. Over the 18 months, participants have regular clinical visits with assessments and sample collection. After 18 months in the trial, participants in both groups have the option to enter into a 12-month extension (up to 30 months total in study) to collect further information on long-term clinical and MRI outcomes.