NCT04761978撤回不适用
Effectiveness and Safety of JAK Inhibitors for the Treatment of Moderate-to-severe Atopic Dermatitis in a Real-life French Multicenter Adult Cohort
University Hospital, Lille2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2021年9月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- reduction in Eczema Area and Severity Index (EASI)
研究概览
简要总结
The aim is to assess effectiveness (EASI, SCORAD, IGA, DLQI, pruritus, sleep loss) and safety (clinical and biological adverse events) of JAK inhibitors in adults with moderate-to-severe atopic dermatitis in a real-life French multicenter retrospective cohort
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •moderate to severe atopic dermatitis
- •treated by JAK inhibitors between december 2020 and september 2021
- •inefficiency, loss of efficiency or contra-indication of previous systemic agent, DUPILUMAB or phototherapy
- •ineligibility to French ongoing clinical trials
排除标准
- •mild atopic dermatitis
- •eligibility to CICLOSPORINE, METHOTREXATE, DUPILUMAB, phototherapy
- •eligibility to French ongoing clinical trials
- •patients' opposition for the use of their records
- •follow up <3 months
结局指标
主要结局
reduction in Eczema Area and Severity Index (EASI)
时间窗: At 3 months
次要结局
- Investigator's Global Assessment (IGA)(at baseline and at 3 months)
- Dermatology Life Quality Index (DLQI)(at baseline and at 3 months)
- patient-reported sleep loss from 0 to 10(at baseline and at 3 months)
- Adverse effects (biological and clinical)(at baseline and at 3 month)
- patient-reported pruritus score from 0 to 10(at baseline and at 3 months)
- SCORing Atopic Dermatitis (SCORAD)(at baseline and at 3 months)
研究者
研究点 (2)
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