ISIS 2302 IN STEROID-DEPENDENT CROHN'S DISEASE

$0M01FY2000RRNIH

University Of Chicago, Chicago IL

Investigators

Linked publications & trials

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Abstract

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.

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