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全身性エリテマトーデス治療のための生物学的製剤の安全性および有効性に関する研究
基本情報
- NCT ID
- NCT02265744
- ステータス
- 完了
- 試験のフェーズ
- 第2相
- 試験タイプ
- 介入
- 目標被験者数
- 730
- 治験依頼者名
- Bristol-Myers Squibb
概要
Study evaluating the safety and efficacy of a novel biologic in the treatment of systemic lupus erythematosus in male and female adults. Patients who qualify will be randomized to either active BMS-931699 or placebo for initially, up to 24 weeks. Patients who complete the initial 24 weeks of treatment and who are responding to therapy will have the option to continue receiving BMS-931699 as part of a long-term extension (LTE). Disease activity and safety will be assessed over the course of the study through laboratory values, various rating scales accepted in systemic lupus erythematosus studies and patient self reporting.
対象疾患
Lupus
介入
BMS-931699(DRUG)
Placebo matching BMS-931699(DRUG)
依頼者(Sponsor)
ブリストル・マイヤーズ スクイブ株式会社(INDUSTRY)