全身性硬化症（SSc）患者におけるトシリズマブの有効性および安全性に関する研究

基本情報

NCT ID

NCT02453256

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

212

治験依頼者名

Hoffmann-La Roche

概要

This study will assess the efficacy and safety of tocilizumab compared with placebo in participants with SSc across approximately 120 planned global study sites. The study will consist of a 48-week, double-blind, placebo-controlled period followed by a 48-week open-label treatment period. Participants will be assigned, in a 1:1 ratio, to double-blind treatment with active tocilizumab or matching placebo. In the open-label period, eligible participants from either arm may receive active tocilizumab.

対象疾患

介入

依頼者（Sponsor）

実施施設 (12)