BioDay Registry: Prospective, Observational Data Collection Regarding the Use of New Systemic Treatment Options in Patients with Atopic Diseases in Daily Practice
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- UMC Utrecht
- 入组人数
- 1,200
- 试验地点
- 14
- 主要终点
- Drug survival
研究概览
简要总结
The BioDay Registry aims to address the need for daily practice data regarding the effectiveness and safety of new systemic treatment options (like biologics and Janus kinase inhibitors) in patients with atopic dermatitis and effect on other atopic comorbidities in a multicenter setting. The registry already consists of several additional modules concerning atopic comorbidities, like food allergy and asthma, and a module for conjunctivitis during biologic treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All adult and paediatric patients treated with new systemic treatments for AD will be asked for participation in the BioDay Registry
排除标准
- •Patients are not eligible for enrolment in case of presumed inability to answer questionnaires or not willing to answer questionnaires and will be excluded.
结局指标
主要结局
Drug survival
时间窗: Drug survival analysis, which is the length of time a patient continues to take a particular drug, will be performed every year, with cumulative results over the years.
To study drug survival and identify factors that affect drug survival.
Assessment of effectiveness
时间窗: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
To assess the effectiveness of new treatments in adult and pediatric patients with AD using physician measured clinical eczema scores as well as patient-reported outcome measures.
Side effects
时间窗: Change from baseline to previous specified timepoints (16 weeks, 1 year, 2 year etc.)
To register objective and subjective side effects and to identify potential risk factors.
次要结局
- Characterization of population(Yearly from baseline up to 5 years)
- Laboratory monitoring(Yearly from baseline up to 5 years)
- Characterization of side effects(Yearly from baseline up to 5 years)
- Long-term safety(Yearly from baseline up to 5 years)
- Comorbidities(Yearly from baseline up to 5 years)
- Dose tapering(Yearly from baseline up to 5 years)
研究者
Dr M.S. de Bruin-Weller
M.S. de Bruin-Weller, dermatologist, MD, PhD
UMC Utrecht