Dupilumab Registry Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Quantified Itch Survey
研究概览
简要总结
The investigators will monitor for the incidence of adverse-events in a prospective, longitudinal, non-interventional and observational real-world sub-study of adults patients with moderate-to-severe AD who are receiving dupilumab as standard-of-care therapy.
详细描述
The investigators will conduct a prospective, longitudinal, non-interventional and observational sub-study of patients receiving dupilumab as normal standard-of-care treatment to assess the efficacy (Specific Aim #1) and safety (Specific Aim #2) of dupilumab for the treatment of moderate-to-severe AD, as well as the prevention and/or mitigation of comorbid health conditions (Specific Aim #3). This study will address the hypotheses that dupilumab will lead to improved long-term control and decreased severity of AD, and that long-term monitoring will shed light on the incidence of adverse drug events.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals aged 18 and over who have been diagnosed with Atopic Dermatitis and are using dupilumab therapy as part of standard of care.
- •Parents of adolescents ages 12 to 17 who have been diagnosed with Atopic Dermatitis and are receiving dupilumab off-label for the management of AD.
排除标准
- •Patients not on dupilumab
- •Those who do not comply with the study requirements
- •Those who do not provide informed consent
结局指标
主要结局
Quantified Itch Survey
时间窗: 1 to 3 months
Quantified Quality of Life Survey
时间窗: 1 to 3 months
Quantified Sleep Survey
时间窗: 1 to 3 months
次要结局
- Occurrence of any SAEs by 24 months(24 months)
- Occurrence of any AEs by 24 months(24 months)
- Occurrence of any infections by 24 months(24 months)
研究者
Jonathan Silverberg
MD, PhD, MPH
Northwestern University