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.

这是对TAK-603/A-165646在克罗恩病患者中的安全性和有效性的II期研究。 这项研究的主要疗效终点将是获得缓解的患者的百分比，该患者定义为150或以下的CDAI分数。 次要终点将包括症状改善的患者百分比，这表明基线CDAI的减少至少50点，被归类为治疗失败的患者的百分比以及医生全球疾病活动评估的变化，患者全球疾病活动的评估，炎症活动的实验室措施和生活评估的实验室测量。