A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of PEGylated Interferon Beta-1a (BIIB017) in Subjects With Relapsing Multiple Sclerosis

The primary objective of this study is to determine the efficacy of peginterferon beta-1a in reducing the annualized relapse rate (ARR) in participants with relapsing multiple sclerosis (RMS) at 1 year. The secondary objectives of this study are to determine whether peginterferon beta-1a, at 1 year when compared with placebo, is effective in reducing the total number of new or newly enlarging T2 hyperintense lesions on brain magnetic resonance imaging (MRI) scans, reducing the proportion of participants who relapse, and slowing the progression of disability.

本研究的主要目的为明确聚乙二醇干扰素β-1a（peginterferon beta-1a）在1年内降低复发型多发性硬化（relapsing multiple sclerosis, RMS）受试者年复发率（annualized relapse rate, ARR）的有效性。本研究的次要目标为，相较于安慰剂组，明确聚乙二醇干扰素β-1a在1年内是否可在以下方面发挥效用：减少脑部磁共振成像（brain magnetic resonance imaging, MRI）扫描中新增或新发增大的T2高信号病灶总数、降低复发受试者的占比，以及延缓残疾进展。