NCT03687359进行中（未招募）不适用
Prospective, Observational, Longitudinal Study in Pediatric Patients With Moderate to Severe Atopic Dermatitis Whose Disease is Not Adequately Controlled With Topical Prescription Therapies or When Those Therapies Are Not Medically Advisable
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 1,860
- 试验地点
- 180
- 主要终点
- Age at onset of atopic dermatitis (AD)
研究概览
简要总结
Primary Objectives:
- To describe the characteristics of pediatric patients with moderate to severe atopic dermatitis (AD) whose disease is not adequately controlled with topical therapies or when those therapies are not medically advisable.
- To evaluate the time-course of AD and selected atopic comorbidities.
Secondary Objectives:
- To characterize disease burden and unmet need.
- To describe real-world treatment patterns (eg, dosing regimens, treatment duration, and reasons for discontinuation and/or switching).
- To document the real-world effectiveness and safety of treatments.
详细描述
The study duration is 60 months.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Age at onset of atopic dermatitis (AD)
时间窗: Baseline (Month 0)
Patient demographics
时间窗: Baseline (Month 0)
Medical history of selected atopic diseases and comorbidities
时间窗: Baseline (Month 0)
Personal and family history of AD and selected atopic diseases
时间窗: Baseline (Month 0)
All prior and current systemic AD treatment
时间窗: Baseline (Month 0)
All prior and current topical therapy and phototherapy for AD (including dose, route and frequency of administration for all AD treatment)
时间窗: Baseline (Month 0)
Presence/severity of AD and selected atopic comorbid conditions
时间窗: Baseline to Month 120
Therapy for selected atopic comorbid conditions
时间窗: Baseline to Month 120
次要结局
- Days missed from school for the patient and days missed from work for the primary caregiver due to AD(Baseline to Month 120)
- Visits to healthcare professionals (HCPs)(Baseline to Month 120)
- Treatments and prescribing patterns for pediatric AD(Baseline to Month 120)
- Changes in physician assessment of disease burden (Eczema Area and Severity Index [EASI])(Baseline to Month 120)
- Changes in physician assessment of disease burden (Body Surface Area [BSA])(Baseline to Month 120)
- Changes in patient/caregiver-reported outcome (PRO): Patient-Oriented Eczema Measure (POEM)(Baseline to Month 120)
- Change in PRO: Children's Dermatology Life Quality Index (CDLQI)/ Infant's Dermatitis Quality of Life (IDQOL)(Baseline to Month 120)
- Change in PRO: Dermatitis Family Impact (DFI)(Baseline to Month 120)
- Change in PRO: Peak Pruritus Numerical Rating Scale (NRS)/ Pruritus (Itch) NRS/ Worst scratching NRS(Baseline to Month 120)
- Change in PRO: Caregiver Global Assessment of Disease (CGAD)(Baseline to Month 120)
- Change in PRO: Days missed from school for the patient and days missed from work for the primary caregiver due to AD since last visit(Baseline to Month 120)
- Change in PRO: Total Nasal Symptom Score (TNSS)(Baseline to Month 120)
- Change in PRO: Pediatric Asthma Questionnaire (PAQ)(Baseline to Month 120)
- Change in PRO: Juniper Asthma Control Questionnaire-5 (ACQ-5)(Baseline to Month 120)
- Adverse event (AE) reporting(Baseline to Month 120)
研究者
研究点 (180)
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