ISIS 2302 IN STEROID-DEPENDENT CROHN'S DISEASE

ISIS 2302 在类固醇依赖性克罗恩病中的应用

• 批准号: 6114531
• 负责人: STEPHEN BRETT HANAUER
• 金额: $ 3.28万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1998
• 资助国家: 美国
• 起止时间: 1998-12-01 至 1999-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6114531
• 关键词: Crohn's disease; clinical research; gastrointestinal disorder chemotherapy; human subject; human therapy evaluation; intravenous administration; prednisone; remission /regression

This is a 6 month, multi-center, double-blind, randomized, placebo-controlled, repeated fixed dose within patient, IV trial of ISIS 2302 in 300 evaluable subjects with steroid-dependent Crohn's disease. Efficacy will be assessed by measuring change in: 1.) CDAI scores; and 2.) IBDG. The primary study endpoints will be the proportion of patients in complete clinical remission (CDAI score < 150 and off all corticosteroids) and in low-dose, steroid-dependent remission (CDAI score < 150 but still taking corticosteroids at doses of less than or equal to 10 mg/d of prednisone) at the end of Week 14 of the study.

这是一项为期 6 个月、多中心、双盲、随机、安慰剂对照、重复固定剂量的 ISIS 2302 IV 试验，在 300 名患有类固醇依赖性克罗恩病的可评估受试者中进行。将通过测量以下方面的变化来评估疗效： 1.) CDAI 评分；和 2.) IBDG。 主要研究终点是在研究第 14 周结束时达到临床完全缓解（CDAI 评分 < 150 且停用所有皮质类固醇）和低剂量类固醇依赖性缓解（CDAI 评分 < 150 但仍服用皮质类固醇剂量小于或等于 10 mg/d 泼尼松）的患者比例。