CDP571 IN MODERATE TO SEVERE CROHNS DISEASE

这项第二阶段、多国家、双盲、安慰剂对照的平行小组研究将评估CDP571在24周内静脉注射20或10毫克/公斤的CDP571，然后用10毫克/公斤的CDP571每周8或12次治疗中重度克罗恩病的安全性和潜力。受试者将全程接受安全监测。主要疗效终点是两周后对治疗有反应的患者的百分比(CDAI&GT；/=70分)。

This phase II, multi-national, double-blind, placebo-controlled, parallel group study will assess the safety and potential of CDP571 in treating patients with moderate to severe Crohn's disease following an IV dose of 20 or 10 mg/kg of CDP571 followed by 8- or 12- weekly dosing with 10 mg/kg CDP571 over 24 weeks. Subjects will be monitored throughout for safety. Primary efficacy endpoint is the percentage of patients who show a response to treatment (a decrease in CDAI >/= 70 points) at 2 weeks.