再発寛解型多発性硬化症（RRMS）のアジア人被験者におけるBG00012（ジメチルフマル酸）の有効性および安全性に関する研究

基本情報

NCT ID

NCT01838668

ステータス

完了

試験のフェーズ

第3相

試験タイプ

介入

目標被験者数

225

治験依頼者名

Biogen

概要

This is a multicenter study conducted in 2 parts: The primary objective in Part I of this study is to determine the efficacy of BG00012 (dimethyl fumarate, DMF) on inflammatory brain magnetic resonance imaging (MRI) lesion activity (Gadolinium-enhancing lesions) when compared with placebo from 4 scans performed at Weeks 12, 16, 20, and 24 in participants with Relapsing Remitting Multiple Sclerosis (RRMS) including participants from the Asia-Pacific region. The secondary objectives in Part I of this study in this study population are to determine whether BG00012, when compared with placebo over 24 weeks, is effective in reducing the cumulative number of new Gadolinium-enhancing lesions from Baseline to Week 24; reducing the number of new or newly enlarging T2 hyperintense lesions on brain MRI scans at Week 24 compared with Baseline. The primary objective in Part II (open label) of this study is to evaluate the long-term safety profile of BG00012 in eligible participants from Part I.

対象疾患

介入

依頼者（Sponsor）

実施施設 (32)