AN OBSERVATIONAL STUDY OF OCRELIZUMAB-TREATED PATIENTS WITH MULTIPLE SCLEROSIS TO DETERMINE THE INCIDENCE AND MORTALITY RATES OF BREAST CANCER AND ALL MALIGNANCIES (VERISMO STUDY)
Aims: The purpose of this study is to assess and characterize the incidence and mortality rates of breast cancer, all malignancies, and the long-term safety regarding serious adverse events (SAEs) among patients with multiple sclerosis (MS) newly exposed to the medication ocrelizumab, (OCREVUS®) under routine clinical care.
Principal Investigator: Afif Hentati, MD
NorthShore Project Number: EH20-012
Contact: Call 847.503.4044 with questions regarding the study
Open to enrollment: Yes
A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF FENEBRUTINIB COMPARED WITH TERIFLUNOMIDE IN ADULT PATIENTS WITH RELAPSING MULTIPLE SCLEROSIS
Aims: the purpose of this study is to compare the efficacy and safety of the study drug, fenebrutinib, to the FDA-approved medication teriflunomide (AUBAGIO) in adult patients with relapsing multiple sclerosis. Primary objectives include measure of time from baseline to fist occurrence of a progression event based on changes in EDSS score, increase in Timed 25-Foot Walk Test, increase in time to complete the 9-hole Peg Test and annualized relapse rate. The pharmacokinetics of fenebrutinib will also be evaluated. Eligible patients with relapsing multiple sclerosis will be randomly assigned to one of the two treatment arms at 1:1. Subjects who complete the initial 96-week-long double-blind treatment phase may be eligible to participate in a 96-week-long open-label fenebrutinib extension phase. Seven patients are expected to be enrolled at NorthShore sites.
Principal Investigator: Afif Hentati, MD
NorthShore Project Number: EH20-357
Contact: Call 847.503.4335 with questions regarding the study
Open to Enrollment: Yes