NCT03992417进行中（未招募）不适用
A Prospective Observational Study of Patients Receiving Dupixent® for Atopic Dermatitis
适应症
干预措施
相关药物
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
- 955
- 试验地点
- 219
- 主要终点
- Baseline Characteristics: Medical history
研究概览
简要总结
Primary Objective:
To characterize the patients who receive Dupixent® (dupilumab) for AD in a real-world setting, with respect to their medical history, socio-demographic and disease characteristics, and prior and concomitant treatments of AD
Secondary Objectives:
- To characterize real-world use patterns of Dupixent® for AD (eg, used regimens, reason for initiation of new treatments, concomitant therapies, treatment durations and reasons for discontinuation and/or switching)
- To assess the long-term effectiveness of Dupixent® in AD patients in a real-world setting
- To assess comorbid atopic conditions and effects of treatment in comorbid atopic conditions in patients who receive Dupixent® for AD
- To collect safety data on study participants
详细描述
Participants enrolled in the study will be followed for 5 years.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female, 12 years or older at the baseline visit. Note: Adolescent participants (at least 12 years old, but less than 18 years) are eligible only after Dupixent® receives the respective country's regulatory approval for use in this age group;
- •Initiating treatment with Dupixent® for AD according to the country-specific prescribing information. Note: Participants may be eligible if they have already initiated treatment with Dupixent® for AD within 6 months before their enrollment in the registry, provided that all core baseline data required (Eczema Area and Severity Index [EASI], Scoring of Atopic Dermatitis [SCORAD], body surface area [of AD involvement] [BSA], Patient-Oriented Eczema Measure [POEM], and Dermatology Life Quality Index [DLQI]) by the registry protocol were captured at the time of initiating Dupixent® treatment and are available for entry in the registry database
- •Able to understand and complete study-related questionnaires
- •Provide signed informed consent or parental/legally acceptable representative consent and/or patient assent where applicable
排除标准
- •Participants who have a contraindication to the drug according to the country-specific prescribing information label
- •Any condition that, in the opinion of the investigator, may interfere with patient's ability to participate in the study, such as short life expectancy, substance abuse, severe cognitive impairment, or other co-morbidities that can predictably prevent the participant patient from adequately completing the schedule of visits and assessments
- •Patients currently participating in any interventional clinical trial which modifies patient care
- •Prior use of Dupixent® within 6 months of the screening visit, or within 6 months of the baseline visit if screening and baseline occur on the same day
- •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
Participants with AD
Adult and adolescent participants with AD initiating treatment with Dupixent® for AD according to the country-specific prescribing information, as part of their usual care as determined by their physician
干预措施: Dupilumab SAR231893 (REGN668) (Drug)
结局指标
主要结局
Baseline Characteristics: Medical history
时间窗: Baseline to Month 60
Baseline Characteristics: Socio-demographics
时间窗: Baseline to Month 60
Baseline Characteristics: Disease characteristics
时间窗: Baseline to Month 60
次要结局
- Physician Assessment: Scoring of Atopic Dermatitis (SCORAD)(Baseline to Month 60)
- Physician Assessment: Body Surface Area Affected (BSA) by Atopic Dermatitis(Baseline to Month 60)
- Physician Assessment: Eczema Area and Severity Index (EASI)(Baseline to Month 60)
- Participant Assessment: Patient Oriented Eczema Measure (POEM)(Baseline to Month 60)
- Participant Assessment: Pruritus Numerical Rating Scale (NRS)(Baseline to Month 60)
- Participant Assessment: Skin Pain or Soreness NRS(Baseline to Month 60)
- Participant Assessment: Skin Feeling Hot NRS(Baseline to Month 60)
- Participant Assessment: Skin Sensitivity NRS(Baseline to Month 60)
- Participant Assessment: Sleep Disturbance NRS(Baseline to Month 60)
- Participant Assessment: Dermatology Life Quality Index (DLQI) for adults and Children Dermatology Life Quality Index (CDLQI) for adolescents(Baseline to Month 60)
- Participant Assessment: Juniper Asthma Control Questionnaire (ACQ-5)(Baseline to Month 60)
- Participant Assessment: Allergic Rhinitis-Visual Analog Scale (AR-VAS)(Baseline to Month 60)
- Participant Assessment: Work Productivity and Activity Impairment Questionnaire for AD (WPAI-AD) for adults and Work Productivity and Activity Impairment Questionnaire+Classroom Impairment Questions for AD (WPAI-CIQ-AD) for adolescents(Baseline to Month 60)
- Participant Assessment: Health Care Resource Utilization Questionnaire(Baseline to Month 60)
- Participant Assessment: 9-Item Treatment Satisfaction Questionnaire for Medication (TSQM-9)(Baseline to Month 60)
- Adverse events (AEs)(Baseline to Month 60)
- Participant Assessment: Atopic Dermatitis Control Tool (ADCT) to be collected optionally(Baseline to Month 60)
研究者
研究点 (219)
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