NCT03894956已完成不适用
Special Drug Use-Results Survey of Evaluating Safety and Effectiveness of Humira in Long Term Treatment in Patients With Hidradenitis Suppurativa
AbbVie37 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2019年5月2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
- 46
- 试验地点
- 37
- 主要终点
- Percentage of participants who reported any adverse drug reactions (ADRs) during the study
研究概览
简要总结
The objective of this study is to evaluate the long-term safety and effectiveness of Humira in patients with Hidradenitis Suppurativa (HS) in real-world clinical practice in Japan.
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
- 0 Years 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have been prescribed Humira by their treating physician as per routine clinical practice for the treatment of HS.
排除标准
- •Participants previously treated with Humira.
- •Participants who do not provide consent.
结局指标
主要结局
Percentage of participants who reported any adverse drug reactions (ADRs) during the study
时间窗: Up to Week 52
ADRs will be coded by Medical Dictionary for Regulatory Activities (MedDRA) dictionary.
Percentage of participants who reported any serious infections during the study
时间窗: Up to Week 52
Percentage of participants with incidence of serious infections are reported.
Percentage of participants who reported any infections during the study
时间窗: Up to Week 52
Percentage of participants with incidence of infections are reported.
次要结局
- Change in C-Reactive Protein (CRP)(From Baseline to Week 52)
- Percentage of participants achieving "Improved" of overall improvement by physician(Up to Week 52)
- Change in Dermatology Life Quality Index (DLQI)(From Baseline to Week 52)
- Percentage of participants achieving Hidradenitis Suppurativa Clinical Response (HiSCR)(Up to week 52)
- Change in Patient's global assessment of skin pain(From Baseline to Week 52)
研究者
研究点 (37)
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