CorEvitas International Adolescent Atopic Dermatitis (AD) Drug Safety and Effectiveness Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- AD epidemiology, presentation, natural history, management, and outcomes
研究概览
简要总结
Prospective observational registry for an adolescent cohort with AD under the care of a dermatology provider. Approximately 1500 subjects and 75 clinical sites in North America and select European countries will be recruited to participate with no defined upper limit for either target.
详细描述
The objective of the registry is to create a cohort of adolescent subjects with AD to evaluate the long-term safety and effectiveness of AD treatments. Data collected will be used to better characterize the natural history of the disease and to extensively evaluate the effectiveness and safety of medications approved for the treatment of AD to support ongoing risk-benefit evaluation by drug manufacturers and regulators. Further, data collected will inform clinical decision making by patients and treating providers. This will be done through standardized data collection including validated instruments for patient-reported outcomes (PROs) and clinician-reported outcomes (ClinROs), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns.
This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
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
- 10 Years 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •To be eligible to participate in this registry, an individual must meet all the following criteria:
- •Has been diagnosed with moderate to severe atopic dermatitis by a dermatologist or a qualified healthcare provider
- •Is 10 - 15 years of age at the time of enrollment.
- •Subject has initiated or is initiating an enrollment-eligible medication at the time of enrollment
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in the registry:
- •Is participating or planning to participate in a blinded clinical trial for an AD drug.
- •Is unwilling or unable to provide standing height measurements.
结局指标
主要结局
AD epidemiology, presentation, natural history, management, and outcomes
时间窗: Through Study completion until the subject is 18 years
The major clinical outcomes include an assessment of the epidemiology of Atopic Dermatitis; to better understand the presentation, natural history, management and outcomes.
次要结局
- Physician reported : Pubertal Progression: Tanner Staging Assessment(Every six Months until a subject is 18 years or the subjects reaches stage 5 of the ranner stangins assessment)
- Patient reported: Peak pruritus (itch) NRS(every 6 months until the subject is 18 years)
- Patient reported: Skin pain NRS(every 6 months until the subject is 18 years)
- Physician reported: Nail changes due to atopic dermatitis (graduated VAS)(every 6 months until the subject is 18 years)
- Eczema Area and Severity Index (EASI) (calculated)(every 6 months until the subject is 18 years)
- Percentage of patients with history of comorbidities(Time Frame: at registry enrollment)
- Patient reported : Patient global assessments of disease control and severity(every 6 months until the subject is 18 years)
- Patient reported: Patient Oriented Eczema Measure (POEM)(every 6 months until the subject is 18 years)
- Patient reported: Fatigue NRS(every 6 months until the subject is 18 years)
- Patient reported: Atopic dermatitis control tool (ADCT)(every 6 months until the subject is 18 years)
- Patient reported: Sleeplessness and average pruritus (itch) NRS (SCORAD)(6 months until the subject is 18 years)
- Physician reported: validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD(every 6 months until the subject is 18 years)
- Atopic dermatitis body surface area (BSA)(every 6 months until the subject is 18 years)
- Physician reported : SCORing Atopic Dermatitis index (SCORAD) (calculated)(every 6 months until the subject is 18 years)
- Patient reported: Children's Dermatology Life Quality Index (CDLQI)(every 6 months until the subject is 18 years)
- Patient reported: Patient Health Questionnaire (PHQ-4)(every 6 months until the subject is 18 years)
- Patient reported: Asthma Control test(every 6 months until the subject is 18 years)