CorEvitas Generalized Pustular Psoriasis (GPP) 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
- 200
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure:GPP epidemiology and Presentation
研究概览
简要总结
Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 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 obtain information on the treatment patterns, disease activity progression, and the development of comorbidities and adverse events in a cohort of patients with GPP. Data collected will be used to better characterize the natural history and longitudinal trajectory of the disease. This will be done through the standardized data collection including 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 GPP 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
- 是
入选标准
- •A subject must meet all the following criteria to participate in the registry:
- •Has been diagnosed with GPP by a dermatologist or a qualified dermatology practitioner.
- •Is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.
- •Is willing to provide consent for participation in the registry.
- •Is willing to provide Personal Information
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 blinded clinical trial evaluating a systemic agent for the treatment or prevention of flares related to GPP.
- •Is enrolled in another CorEvitas registry for a dermatological condition. Subjects enrolled in another CorEvitas registry must be exited to be eligible for enrollment into the GPP Registry
研究组 & 干预措施
Generalized Pustular Psoriasis (GPP)
Pts presenting to enrolling sites across the North America are invited to enroll if eligible
结局指标
主要结局
Primary Outcome Measure:GPP epidemiology and Presentation
时间窗: Through study completion, an average of 10 years
The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation and natural history.
GPP management, and outcomes
时间窗: Through study completion, an average of 10 years
The major clinical outcome include an assessment of the epidemiology of GPP; to better understand the management and outcomes.
次要结局
未报告次要终点