CDP571 IN STEROID DEPENDENT PATIENTS W/ CROHNS DISEASE

CDP571 在类固醇依赖性克罗恩病患者中的应用

• 批准号: 6304557
• 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/6304557
• 关键词: Crohn's disease; chemoprevention; clinical research; drug screening /evaluation; gastrointestinal disorder chemotherapy; hormone therapy; human subject; human therapy evaluation; immunotherapy; monoclonal antibody; relapse /recurrence; steroid hormone

This phase II, multi-national, double-blind, placebo-controlled, parallel group, 16 week study will assess the safety and potential of CDP571 to prevent disease flare while allowing steroid withdrawal in steroid-dependent patients with Crohn's disease following and IV dose of 20 mg/kg and then, 8 weeks later, 10 mg/kg of CDP571. Subjects will be montiored throughout for safety. Primary efficacy endpoint is the percentatge of patients who have not experienced a disease flare and who no longer require steroid therapy at Week 10.

这项II期、多国、双盲、安慰剂对照、平行组、16周研究将评估CDP 571的安全性和潜力，以预防克罗恩病的类固醇依赖性患者在IV剂量为20 mg/kg，然后8周后10 mg/kg的CDP 571后疾病发作，同时允许类固醇戒断。 将全程监测受试者的安全性。 主要疗效终点是第10周时未发生疾病发作且不再需要类固醇治疗的患者的死亡率。