Prospective, Observational, Longitudinal Study in Paediatric Patients With AD, Treated With Dupilumab in Spain
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
- 143
- 试验地点
- 15
- 主要终点
- Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age
研究概览
简要总结
This is a multicentre, prospective, non-interventional study that aims to describe the treatment patterns of in Atopic dermatitis (AD) patients aged 6 months to 11 years old in Spain: patients' characteristics, disease characteristics, prior treatments for and treatment prescription modalities. As well as to document the real-world effectiveness and safety of dupilumab during the two years of follow up. No diagnostic or therapeutic intervention outside of routine clinical practice will be applied.
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
- 6 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged 6 months to 11 years old at baseline.
- •Patients with severe Atopic dermatitis (AD) according to the investigator's assessment.
- •Patients initiating dupilumab (in those patients initiated retrospectively 2 months before the start of the study, the baseline information must be correctly filled out in the medical records).
- •Signed informed consent by the parent/legally acceptable representative and assent by the patient appropriate to the patient's age.
排除标准
- •Patients who are participating in an interventional clinical trial that modifies patient care.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Dupilumab
The information will be collected during consultation as part of the patient's usual follow-up.
干预措施: Dupilumab (Drug)
结局指标
主要结局
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Age
时间窗: At baseline
Demographic characteristic of pediatric patients initiating treatment with dupilumab for Severe AD: Gender
时间窗: At baseline
Medical history of atopic comorbidities
时间窗: At baseline
Selected atopic comorbidities over time will be reported.
Characteristic of pediatric patients initiating treatment with dupilumab for Severe AD:Body mass index (BMI)
时间窗: At baseline
Medical history characteristics of pediatric patients initiating treatment with dupilumab for Severe AD
时间窗: At baseline
Including course of AD, recent AD treatment history, family history.
Medical history of non-atopic diseases
时间窗: At baseline
次要结局
- Description of real-world treatment patterns (other treatments): Other type of treatment(From baseline up to 24 months)
- Description of real-world treatment patterns (other treatments): Duration of treatment(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the Infant's Dermatology Life Quality Index score(From baseline up to 24 months)
- Description of real-world treatment patterns (other treatments): Name of treatment(From baseline up to 24 months)
- Description of real-world treatment patterns (other treatments): Reason for discontinuation (if applicable)(From baseline up to 24 months)
- Description of real-world treatment patterns: Dupilumab dosage(From baseline up to 24 months)
- Description of real-world treatment patterns: Dupilumab frequency of administration(From baseline up to 24 months)
- Description of real-world treatment patterns: Dupilumab reason for discontinuation(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the Children's Dermatology Life Quality Index score(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the Dermatitis Family Impact (DFI) questionnaire(From baseline up to 24 months)
- Participant-caregiver assessment: Change from baseline in the patient's Worst Itch Numerical Rating Scale (WI-NRS)(From baseline up to 24 months)
- Caregiver assessment: Change from baseline in the patient's Worst Itch Scale Numerical Rating Scale (WSI-NRS)(From baseline up to 24 months)
- Physician assessment: Percent change from beseline in the Body Surface Area (BSA) (%) affected by AD(From baseline up to 24 months)
- Physician assessment: Change in Proportion of patients with Validated Investigator's Global Assessment (IGA)(From baseline up to 24 months)
- Physician assessment: Change from baseline in Biomarkers(From baseline up to 24 months)
- Number of Adverse Events (AE) / Serious Adverse Events (SAE) / Adverse Event of Special Interest (AESI)(From date of signed ICF, up to 24 months)
- Physician assessment: Change from baseline in the eczema severity using the Eczema Area and Severity Index (EASI)(From baseline up to 24 months)
- Health Care Resource Utilization (HCRU) Questionnaire(From baseline up to 24 months)