CDP571 IN MODERATE TO SEVERE CROHNS DISEASE

这项II期、多国、双盲、安慰剂对照、平行组研究将评估CD571治疗中度至重度克罗恩病患者的安全性和潜力，该患者在24周内静脉注射20或10mg /kg CDP571，然后每周8或12次给药10mg /kg CDP571。为了安全起见，受试者将全程受到监控。主要疗效终点是2周时对治疗有反应的患者百分比（CDAI >/= 70分）。

This phase II, multi-national, double-blind, placebo-controlled, parallel group study will assess the safety and potential of CD571 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.