NCT03001115已完成不适用
Post-Marketing Surveillance of Adalimumab in Korean Hidradenitis Suppurativa Patients Under the "New-Drug Re-examination
AbbVie19 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2017年3月10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
- 17
- 试验地点
- 19
- 主要终点
- Assessing adverse events
研究概览
简要总结
The objective of this study is to evaluate the safety profile of Adalimumab for Hidradenitis Suppurativa (HS) participants in normal medical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant who are eligible to be treated with adalimumab for HS in accordance with the approved Korean label
- •Participant must provide written authorization form to use their personal health data prior to the participating in the study.
排除标准
- •Participant who are contraindications to adalimumab as listed on the approved Korean label.
- •Participant who is participating on other clinical trials.
结局指标
主要结局
Assessing adverse events
时间窗: Up to 70 days following the last administration of Humira®
Adverse event information is collected to assess prevalence of safety.
次要结局
- Change from baseline in Dermatology Life Quality Index (DLQI)(Week 0 (baseline), Week 12, and Week 24)
- Change from baseline in Hidradenitis Suppurativa Clinical Response (HiSCR)(Week 0 (baseline), Week 12, and Week 24)
研究者
研究点 (19)
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