ISIS 2302 IN STEROID-DEPENDENT CROHN'S DISEASE

这是一项为期6个月，多中心，双盲，随机，安慰剂对照，重复固定剂量的患者IV试验，在300名可评估的类固醇依赖性克罗恩病患者中进行ISIS 2302。通过测量以下方面的变化来评估疗效：CDAI分数;和2)。IBDG。主要研究终点将是在研究第14周结束时临床完全缓解（CDAI评分< 150，停用所有皮质类固醇）和低剂量类固醇依赖缓解（CDAI评分< 150，但仍服用皮质类固醇，剂量小于或等于10mg /d的泼尼松）的患者比例。

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.