ISIS 2302 IN STEROID-DEPENDENT CROHN'S DISEASE

这是一个6个月，多中心，双盲，随机，安慰剂

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.) IBDQ. 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.