TAK 603/A 165646 IN PATIENTS W/ CROHNS DISEASE

TAK 603/A 165646 用于克罗恩病患者

• 批准号: 6303921
• 负责人: KIM L ISAACS
• 金额: $ 0.02万
• 依托单位: UNIV OF NORTH CAROLINA CHAPEL HILL
• 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 2000-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6303921
• 关键词: Crohn's disease; antirheumatic agents; antiulcer drug; clinical research; drug screening /evaluation; gastrointestinal agents; gastrointestinal disorder chemotherapy; human subject; human therapy evaluation; immunomodulators; quinoline

This is a Phase II study of the safety and efficacy of TAK-603/A-165646 in patients with Crohn's disease. The primary efficacy endpoint of this study will be a percentage of patients achieving remission, defined as a CDAI score of 150 or less. Secondary endpoints will include percentage of patients achieving improvement in symptoms, indicated by a reduction in baseline CDAI by at least 50 points, percentage of patients classified as treatment failure, and changes in physicians global assessment of disease activity, patients global assessment of disease activity, laboratory measure of inflammatory activity and qualify of life evaluations.

这是一项在克罗恩病患者中评价TAK-603/A-165646安全性和疗效的II期研究。 本研究的主要疗效终点将是达到缓解的患者百分比，定义为CDAI评分为150或更低。次要终点将包括症状改善的患者百分比，表示为基线CDAI降低至少50分，分类为治疗失败的患者百分比，以及医生对疾病活动性的总体评估的变化，患者疾病活动的总体评估、炎症活动的实验室测量和生活质量评估。