Evaluation of Biomarkers of Atopic Dermatitis in Pediatric Patients Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 266
- 试验地点
- 96
- 主要终点
- Biomarker identification: New presentation or resolution of atopic comorbidity
研究概览
简要总结
Primary Objective:
To explore associations between biomarkers of atopic dermatitis (AD) and:
- Disease state and time course of AD,
- Disease state and evolution of selected atopic comorbid conditions,
- Effectiveness of specific AD treatments.
详细描述
The estimated enrollment duration is approximately 2 years, while duration of observation is approximately 5 years.
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
- 0 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participation in the OBS15333 pediatric atopic dermatitis (AD) registry.
- •Signed informed consent by the parent/legally acceptable representative and assent by the participant appropriate to the participant's age.
排除标准
- •Not applicable.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
结局指标
主要结局
Biomarker identification: New presentation or resolution of atopic comorbidity
时间窗: Up to 5 years
Identification of biomarkers associated with onset of a new atopic comorbidity or resolution of an existing atopic comorbidity
Biomarker identification: Demographics
时间窗: Baseline
Identification of biomarkers associated with demographic characteristics
Biomarker evaluation: High versus low disease severity across participants
时间窗: Up to 5 years
Examination of biomarker expression in participants with high disease severity versus those with low disease severity
Biomarker identification: Introduction of new systemic treatment
时间窗: Up to 5 years
Identification of biomarkers associated with introduction of new systemic treatment
Biomarker identification: Response to systemic treatment
时间窗: Up to 5 years
Identification of biomarkers associated with response to systemic treatment
Biomarker identification: Baseline disease characteristics
时间窗: Baseline
Identification of biomarkers associated with disease characteristics at study entry (eg, disease severity, presence of other co-morbidities)
Biomarker identification: Changes in disease severity
时间窗: Up to 5 years
Identification of biomarkers associated with disease severity increases/decreases (including remission) over time
Biomarker identification: Loss of response to systemic treatment
时间窗: Up to 5 years
Identification of biomarkers associated with loss of response to systemic treatment
Biomarker evaluation: Start of systemic therapy early in life versus later in life
时间窗: Up to 5 years
Examination of whether biomarker expression in participants who started systemic therapy for AD early in life (within 6 months) differs from those who started it later in life
次要结局
未报告次要终点