中等度から重度の活動性潰瘍性大腸炎患者におけるウステキヌマブ導入療法および維持療法の安全性と有効性を評価する研究

基本情報

NCT ID: NCT02407236
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: 961
治験依頼者名: Janssen Research & Development, LLC

概要

The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as subcutaneous (SC) administration in maintenance study in participants with moderately to severely active Ulcerative Colitis (UC) who have demonstrated a clinical response to Induction treatment with IV ustekinumab.

対象疾患

Colitis, UlcerativeInflammatory Bowel Diseases

介入

Placebo IV(DRUG)

Placebo SC(DRUG)

Ustekinumab IV(DRUG)

Ustekinumab SC(DRUG)

依頼者（Sponsor）

ヤンセンファーマ株式会社(INDUSTRY)