TREAT NL (TREatment of ATopic Eczema, the Netherlands) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Mean change in POEM (Patient-Oriented Eczema Measure) score
研究概览
简要总结
The TREAT NL (TREatment of ATopic eczema, the Netherlands) registry is a national registry for children and adults with moderate-to-severe atopic eczema aiming to gather data on their prescribed photo- and systemic immunomodulating therapies. Atopic eczema is a common, chronic, itchy, inflammatory skin disease that can have a major impact on the quality of life of patients and their immediate surroundings.
Serious atopic eczema patients are treated by means of photo- or systemic immunomodulating therapy. Of these mostly off-label applied therapies, there is insufficient evidence on the short and long term for their effectiveness, safety and cost-effectiveness. Moreover, good comparative research and real-life data are lacking. With the arrival of new expensive treatments it is crucial to get insight into these treatments in order to improve quality of care.
By means of a prospective registry these data can be collected and help to obtain information for clinical practice, for answering research questions, for reducing costs and implementing the results by guidelines and decision aids.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient has a diagnosis of atopic eczema, based on the U.K. working party's diagnostic criteria;
- •Starts with any type of phototherapy (e.g. UVB) or systemic immunomodulating therapy (e.g. cyclosporin, systemic glucocorticosteroids, azathioprine, methotrexate, mycophenolic acid, dupilumab);
- •Has voluntarily signed and dated an informed consent prior to any study related procedure or has a legal representative to do so and is willing to comply with the requirements of this study protocol.
排除标准
- •Patient uses only (systemic) antibiotics or antihistamines;
- •Patient starts with systemic immunomodulating therapy for another indication than atopic eczema;
- •Insufficient understanding of the study by the patient or parent/legal representative.
结局指标
主要结局
Mean change in POEM (Patient-Oriented Eczema Measure) score
时间窗: 5 years
Patient-reported outcome measure for symptoms of atopic eczema
Mean change in PGA (Patient's Global Assessment) score
时间窗: 5 years
Patient-reported outcome measure for global disease severity
Mean change in DLQI (Dermatology Life Quality Index) score
时间窗: 5 years
Patient-reported outcome measure for skin-related quality of life
Drug survival of the therapies
时间窗: 5 years
Assessment of the duration until discontinuation of a drug together with the reason thereof
Mean change in EASI (Eczema Area and Severity Index) score
时间窗: 5 years
Investigator-assessed outcome measure for disease severity at physical examination
Mean change in IGA (Investigator's Global Assessment) score
时间窗: 5 years
Investigator-assessed outcome measure for global disease severity
Mean time to reach a change in EASI (Eczema Area and Severity Index) score of 50%
时间窗: 5 years
Investigator-assessed outcome measure for disease severity at physical examination
The occurrence of severe adverse events
时间窗: 5 years
Any undesirable experience of severe nature occurring to a subject is reported
次要结局
未报告次要终点
研究者
Angela Bosma
Co-investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)