Treatment and Medical Care of Patients With Moderate-to-severe Atopic Dermatitis - Swiss National Clinical Registry TREATswitzerland
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 700
- 试验地点
- 9
- 主要终点
- Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis
研究概览
简要总结
As structured and detailed data on the management of AD, a common chronic inflammatory skin disease which has a high impact on patients' quality of life and socioeconomic burden, are not available in Switzerland, the planned registry will overcome this gap. It will provide data on the medical care of patients with AD for health care research and allow to study the efficacy and safety of approved and available therapies for AD in daily life.
详细描述
A prospective, non-interventional, national multicenter study in patients with moderate-to-severe AD. According to the availability of approved systemic drugs for the treatment of AD, the study will include children ≥12 years, adolescents and adult patients.
The general goal of the AD registry TREATswitzerland is to provide the scientific community with a disease-oriented prospective cohort of patients suffering from moderate-to-severe AD.
The primary objective of the AD registry is the documentation of medical care given to patients with moderate-to-severe AD in order to assess the appropriateness of care.
Further objectives of the AD registry are:
- to evaluate the psychosocial impact of AD;
- to provide up-to-date epidemiologic data that allow investigating risk factors for favorable or unfavorable disease courses and comorbidities; and
- to establish a research network and foster clinical research projects.
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
- •Age ≥ 12 years
- •AD according to the UK Working Party's Diagnostic Criteria (28)
- •Moderate to severe AD as defined by
- •objective SCORAD > 20 or IGA ≥ 3 (moderate) or
- •currently on systemic antiinflammatory therapy for AD or
- •previous systemic antiinflammatory therapy for AD within past 24 months
排除标准
- •refusal to sign the informed consent form
结局指标
主要结局
Evaluation of the type of systemic therapy used in patients with moderate-to-severe atopic dermatitis
时间窗: 24 months
assess medical substances given systemically to treat AD
次要结局
- assessment of past treatment and current treatment(24 months)
- assessment of past and current comorbidities(24 months)
- change in RECAP (Recap of atopic eczema)(24 months)
- assessment of patients demographic data(24 months)
- assessment of concomitant topical therapy for AD and concomitant treatment(24 months)
- change in EASI (Eczema Area and Severity Index)(24 months)
- change in POEM (Patient Oriented Eczema Measure)(24 months)
- change in subjective and objective SCORAD (SCORing Atopic Dermatitis)(24 months)
- change in DLQI (Dermatology Life Quality Index)(24 months)