NCT01464333已完成不适用
Humira® for Subcutaneous Injection Protocol for Special Investigation (Long-term Treatment for Crohn's Disease Patients)
AbbVie (prior sponsor, Abbott)0 个研究点目标入组 511 人开始时间: 2011年12月16日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 511
- 主要终点
- Number of Participants With Adverse Events
研究概览
简要总结
This study of Humira will be conducted to obtain information on the safety (especially profile of malignant tumors and serious infections) and effectiveness in patients with Crohn's disease who are receiving Humira for a long period of time.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Crohn's disease indicated for Humira treatment with the recommended dosage regimen
- •Patients with no past- or present malignant tumors
- •Patients who are not currently receiving Humira
排除标准
- 未提供
结局指标
主要结局
Number of Participants With Adverse Events
时间窗: From first dose of Humira up to 3 years
An adverse event was any untoward or unintended symptoms (including abnormal laboratory findings), condition or illness, which are not always related to Humira. Please see Adverse Event section below for more details.
次要结局
- Change in Crohn's Disease Activity Index (CDAI) Score Over Time(From first dose of Humira up to 3 years)
- Percentage of Participants With Endoscopic Remission Over Time by Intestine Segment (Large Intestine, Small Intestine, and Both Large and Small Intestine)(From first dose of Humira up to 3 years)
- Change in C-Reactive Protein (CRP) Levels Over Time(From first dose of Humira up to 3 years)
- Change In Work Productivity and Activity Impairment (WPAI): Crohn's Disease (CD) Absenteeism Over Time(From first dose of Humira up to 3 years)
- Change in WPAI: CD Overall Work Impairment Over Time(From first dose of Humira up to 3 years)
- Change in WPAI: CD Presenteeism Over Time(From first dose of Humira up to 3 years)
- Change in WPAI: CD Activity Impairment Over Time(From first dose of Humira up to 3 years)
研究者
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