NCT02786576已完成不适用
Effectiveness of Adalimumab in Moderate to Severe HidrAdenitis SuppuRativa Patients - a Multi cOuNtry studY in Real Life Setting - HARMONY Study
AbbVie83 个研究点 分布在 7 个国家目标入组 236 人开始时间: 2016年7月5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
- 236
- 试验地点
- 83
- 主要终点
- Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response
研究概览
简要总结
This study will assess the effects of adalimumab treatment in moderate to severe Hidradenitis Suppurativa (HS) patients in the real world setting. The objectives of this study are to estimate the effectiveness of adalimumab treatment on disease severity, to estimate the impact of adalimumab treatment on patients' quality of life, psychological effect, work productivity and healthcare resource utilization and to describe treatment practices over the study period.
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
- •Clinical diagnosis of moderate to severe Hidradenitis Suppurativa
- •The decision to treat with adalimumab (Humira) is made by the physician in accordance with the local label (Summary of Product Characteristics; product label) prior to any decision to approach the participant to participate in this study
- •Participants willing to be involved in the study and to sign patient authorization form to use and disclose personal health information (or informed consent, where applicable)
排除标准
- •Participants in a clinical interventional study
- •Participants treated with adalimumab prior to baseline visit
结局指标
主要结局
Proportion of participants with moderate to severe Hidradenitis Suppurativa (HS) who achieve a clinical response
时间窗: At Week 12
Clinical response is evaluated by using the Hidradenitis Suppurativa clinical response measure (HiSCR)
次要结局
- Changes from baseline in Dermatology Quality of Life Index (DLQI)(From Week 0 to Week 52)
- Proportion of participants with moderate to severe HS who achieve a clinical response(Up to week 52)
研究者
研究点 (83)
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