An Open Label Extension Study of Ublituximab in Subjects with Relapsing Multiple Sclerosis

relapsing multiple sclerosis

Relapses: • Annualized Relapse Rate (ARR) is defined as the number of relapses per- subject year. The estimate of ARR will be the total number of relapses divided by the sum of duration on study treatment (years)., MRI parameters: • T1 gadolinium enhancing (Gd-enhancing) • T1 hypointense lesions • T2 lesions • Brain atrophy, Disability: • 24-Week Confirmed Disability Progression (CDP) • 24-Week Confirmed Disability Improvement (CDI) • Mean change from baseline in EDSS score, No Evidence of Disease Activity (NEDA): • NEDA is defined as subjects without relapses, MRI activities (no T1 Gd-enhancing lesions and no new/enlarging T2 lesions), and no 24-week confirmed disability progression. • The percent of subjects with no evidence of disease activity, Cognition and Function: • Cognition will be measured by Symbol Digit Modalities Test (SDMT) • Function will be measured by Multiple Sclerosis Functional Composite (MSFC), Safety Endpoints: All AEs will be reported and evaluated during the treatment period using NCI CTCAE v.5.0 grading system; the number and severity of infusion-associated events; the number and severity of infectious AEs; any clinically significant changes in laboratory or vital sign measurements; the incidence of anti-drug antibodies

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Croatia, Poland