CDP571 IN MODERATE TO SEVERE CROHNS DISEASE

CDP571 患有中度至重度克罗恩病

• 批准号: 6304558
• 负责人: STEPHEN BRETT HANAUER
• 金额: $ 3.28万
• 依托单位: UNIVERSITY OF CHICAGO
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-12-01 至 2001-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6304558
• 关键词: Crohn's disease; clinical research; dosage; drug screening /evaluation; human subject; human therapy evaluation; immunotherapy; intravenous administration; monoclonal antibody; outcomes research; prognosis

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.

这项II期、多国、双盲、安慰剂对照、平行组研究将评估CDP571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）。