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TAK 603/A 165646 IN PATIENTS W/ CROHNS DISEASE

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
项目类别：
财政年份：
1999
资助国家：
美国
项目状态：
已结题
起止时间：
1999-12-01 至 2000-11-30
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

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中文摘要
翻译
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。
英文摘要
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.
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会议论文
CLINICAL TRIAL: MULTI-SITE TRIAL OF AZATHIOPRINE DOSING IN CROHN'S DISEASE
MULTI-SITE TRIAL OF AZATHIOPRINE DOSING IN CROHN'S DISEASE
AZATHIOPRINE LOADING TO DECREASE RESPONSE TIME IN CROHN'S DISEASE
TAK 603/A 165646 IN PATIENTS W/ CROHNS DISEASE
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