CorEvitas Alopecia Areata (AA) 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
- 5,000
- 试验地点
- 1
- 主要终点
- Alopecia epidemiology, presentation, natural history, management, and outcomes
研究概览
简要总结
Prospective, observational cohort study for subjects with AA under the care of a dermatology provider. Approximately 5,000 subjects and 100 clinical sites in North America 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 AA subjects to study long-term safety and effectiveness of AA treatments. Because the long-term understanding of safety and efficacy is still limited even after regulatory approval,enrollment and long-term follow-up of a large number of diverse real-world patients exposed to therapies of interest is important to understand safety and effectiveness. The observational structured 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 AA to support ongoing risk benefit evaluation by drug manufacturers and regulators.Further, data collected will inform clinical decision making by subjects and treating providers. This will be done through the standardized collection of validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of AA for the purposes of clinical, market, or outcomes research. 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A subject must meet all the following criteria to participate in the registry:
- •Has been diagnosed with alopecia areata by a dermatologist or a qualified dermatology practitioner.
- •Is at least 18 years of age or older.
- •Is willing to provide Personal Information.
- •Is prescribed or starting an Enrollment Eligible Medication at the time of enrollment.
排除标准
- •Any of the following would exclude the subject from participating in the registry:
- •Is participating or planning to participate in a double-blind randomized trial for an AA drug. Note:
- •Concurrent participation in another observational registry or open-label Phase 3b/4 trial is allowed.
研究组 & 干预措施
Alopecia Areata
Pts presenting to enrolling sites across the US are invited to enroll if eligible
结局指标
主要结局
Alopecia epidemiology, presentation, natural history, management, and outcomes
时间窗: A minimum of 10 years from last patient enrolled
The major clinical outcomes include an assessment of the epidemiology of AA; to better understand the presentation, natural history, management and outcomes.
次要结局
- Physician Reported - Dermatology Life Quality Index (DLQI)(every 6 months for 10 years)
- Physician Reported - ClinRo Measure for Eyebrow, Eyelash Hair Loss & Nail Appearance(every 6 months for 10 years)
- Physician Reported - Alopecia Areata Scale (AAS)(every 6 months for 10 years)
- Patient Reported - Scalp Hair Assessment PRO(every 6 months for 10 years)
- Physician Reported - Skindex-16(every 6 months for 10 years)
- Physician Reported - Alopecia Areata Symptom Impact Scale (AASIS)(every 6 months for 10 years)
- Physician Reported - Alopecia Areata-Investigator Global Assessment (AA-IGA)(every 6 months for 10 years)
- Patient Reported - PRO Measure for Eyebrows, Eyelashes & Nail Apperance(every 6 months for 10 years)
- Physician Reported - Severity of Alopecia Tool (SALT)(every 6 months for 10 years)
- Patient Reported - Work Productivity and Activity Impairment (WPAI)(every 6 months for 10 years)