A randomized study of natalizumab dosing regimens for relapsing-remitting multiple sclerosis.

ABSTRACT:

Background

REFINE was an exploratory, dose- and frequency-blinded, prospective, randomized, dose-ranging study in relapsing-remitting multiple sclerosis (RRMS) patients.

Objective

To examine the efficacy, safety, and tolerability of natalizumab administered via various regimens in RRMS patients.

Methods

Clinically stable RRMS patients previously treated with 300 mg natalizumab intravenously for ⩾12 months were randomized to one of six natalizumab regimens over 60 weeks: 300 mg administered intravenously or subcutaneously every 4 weeks (Q4W), 300 mg intravenously or subcutaneously every 12 weeks (Q12W), or 150 mg intravenously or subcutaneously Q12W. The primary endpoint was the mean cumulative number of combined unique active magnetic resonance imaging (MRI) lesions a

SUBMITTER: Trojano M 

PROVIDER: S-EPMC8597184 | biostudies-literature | 2021 Dec

REPOSITORIES: biostudies-literature