NCT05674695招募中不适用
Spanish Academy of Dermatology and Venereology Registry of Atopic Dermatitis Therapy
Fundación Academia Española de Dermatología9 个研究点 分布在 1 个国家目标入组 2,500 人开始时间: 2019年1月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 2,500
- 试验地点
- 9
- 主要终点
- Relative rate of adverse events
研究概览
简要总结
The Spanish Registry of Systemic therapy in atopic eczema, BIOBADATOP, assesses drug safety and treatment effectiveness as well as treatment impact on quality of life in children and adults with atopic eczema receiving systemic immuno-modulatory therapies in Spanish daily practice.
The main objectives are:
- To assess short and long-term safety of systemic therapies (including phototherapy) for atopic eczema (pharmacovigilance).
- To assess short and long-term effectiveness of systemic therapies, providing a basis for shared decision making and guidelines.
Secondary objectives are:
- To assess short and long-term safety of topical therapies for atopic eczema.
- To assess effectiveness of different methods of care, including patient training.
- To describe atopic dermatitis comorbidities.
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
- •Paediatric and adult patients with atopic eczema who due to the severity of their disease and/or impact on quality of life are commencing on or switching to a specific systemic immuno-modulatory agent (e.g. CyA, AZA, MTX or new/biologic treatments) for the first time in their life (might have received others, but not this specific one).
- •Diagnosis of atopic eczema in keeping with the UK/Irish diagnostic criteria.
- •Willingness to comply with all study requirements.
排除标准
- •Insufficient understanding of the study by the patient and/or parent/guardian.
- •Patients who are currently participating in a randomised clinical trial.
- •Intention to move to a different geographical area in a short-term (next 3 months).
结局指标
主要结局
Relative rate of adverse events
时间窗: through study completion, an average of 3 years
Compared to a standard drug ( such as cyclosporine). Crude and adjusted
Rates of adverse events
时间窗: through study completion, an average of 3 years
For each drug or drug type
次要结局
- Change in Eczema Area and Severity Index (EASI)(Change between baseline and 6 months)
- Change in Patient Oriented Eczema Measure (POEM)(Change between baseline and 6 months)
研究者
研究点 (9)
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