Open-label, Observational, Prospective, 9-month Study to Assess the Efficacy of Ofatumumab on Microglia in Patients With Relapsing Forms of Multiple Sclerosis
Aims: Specific Aim 1: To determine the effect of Ofatumumab on microglial activation in MS over 9 months. Specific Aim 2: To determine the time course of effect of Ofatumumab on microglial activation and its relationship with peripheral B-cell depletion, serum neurofilament light (sNfL) chain and glial-fibrillary acid protein (GFAP) levels and other serum biomarkers Specific Aim 3: To determine the relationship of PET changes following Ofatumumab initiation with 3T MRI changes and clinical parameters.
• Patients diagnosed with active, relapsing MS course. Active disease is defined by at least 1 relapse during the previous 1 year or 2 relapses during the previous 2 years or a positive gadolinium-enhancing MRI scan or MRI scan with new or unequivocally enlarging T2 lesions in previous year.
• Age 18 to 60 years
• EDSS 0 to 5.5
• Subjects either untreated or treated with disease modifying therapies other than those listed in exclusion criteria
• Agree to start treatment with ofatumumab and comply with study procedures for the duration of the study
• No other systemic disease or neurological disorders requiring chronic or acute steroid or other immunosuppressive treatment
• No known hypersensitivity reactions to contrast agents
• None of the exclusion criteria