皮膚筋炎におけるBAF312の安全性と有効性

基本情報

NCT ID: NCT02029274
ステータス: 中止
試験のフェーズ: 第2相
試験タイプ: 介入
目標被験者数: 17
治験依頼者名: Novartis

概要

This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .

対象疾患

Active Dermatomyositis

介入

BAF312(DRUG)

Placebo(DRUG)

依頼者（Sponsor）

ノバルティスファーマ株式会社(INDUSTRY)