NCT02896920已完成不适用
Canadian Humira Post Marketing Observational Epidemiological Study : Assessing Humira Real-life Effectiveness and Impact on Hidradenitis Suppurativa (HS) Burden of Illness and Health Care Resources Utilization
AbbVie22 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2016年9月20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
- 165
- 试验地点
- 22
- 主要终点
- Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 24
研究概览
简要总结
This study assesses Humira's® real-life effectiveness in the management of dermatological manifestations of moderate to severe Hidradenitis Suppurativa (HS).
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
- •Has a clinical diagnosis of moderate to severe HS according to the treating physician judgment
- •Need a change in ongoing therapy for any reason, but not limited to inadequate response, intolerance, sub-optimal compliance, or patient preference. Patient will be approached to participate in the study after a decision to change patient's therapy for Humira® is made by the treating physician.
- •Has provided written informed consent (Patient Authorization) for participation in the study
排除标准
- •Is participating in a clinical interventional study
- •Was treated with Humira®, or any other biologic agents for HS prior to baseline visit
- •Has any other active skin disease or condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of HS
结局指标
主要结局
Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 24
时间窗: At Week 24
The HiSCR measure is defined as at least a 50% reduction in the Abscess and inflammatory nodule (AN) count with no increase in abscess count and no increase in draining fistula count relative to baseline.
次要结局
- Proportion of participants who experience flare(Up to Week 52)
- Change from Baseline in Health Utility Index Mark 3 (HUI3)(From Week 0 (baseline) to Week 52)
- Change from Baseline in Hospital Anxiety and Depression Scale (HADS)(From Week 0 (baseline) to Week 52)
- Change from Baseline in International Index of Erectile Function (IIEF)(From Week 0 (baseline) to Week 52)
- Change from Baseline in Health Care Resource Utilization (HCRU) associated with HS(From Week 0 (baseline) to Week 52)
- Change from Baseline in Patient Global Assessment of HS (HS-PtGA)(From Week 0 (baseline) to Week 52)
- Proportion of participants achieving clinical response using the Hidradenitis Suppurativa Clinical Response measure (HiSCR) at week 52(At Week 52)
- Change from Baseline in Female Sexual Function Index (FSFI)(From Week 0 (baseline) to Week 52)
- Proportion of participants who experience worsening of HS by >= 1 Hurley Stage in >= 1 affected anatomic region(Up to Week 52)
- Change from Baseline in Hidradenitis Suppurativa Symptom Assessment (HSSA)(From Week 0 (baseline) to Week 52)
- Change from Baseline in Hidradenitis Suppurativa Impact Assessment (HSIA)(From Week 0 (baseline) to Week 52)
- Change from Baseline in Work Productivity and Activity Impairment Questionnaire: Specific Health Problem V2.0 (WPAI: SHP)(From Week 0 (baseline) to Week 52)
- Number of days where participants experience HS flare-up(Up to Week 52)
研究者
研究点 (22)
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