CorEvitas Psoriasis (PSO) Registry
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Number of patients with adverse events (AEs) or serious adverse events (SAEs).
研究概览
简要总结
The primary objective of the CorEvitas Psoriasis Registry is to study the comparative safety of approved psoriasis therapies in a North American cohort of psoriasis subjects treated by dermatologists. This includes assessing the incidence and nature of adverse events of special interest, including malignancy, in a real world population of psoriasis patients on new biologic therapies (e.g. secukinumab). Secondary objectives include analyzing the epidemiology and natural history of the disease, comorbidities, current treatment practices, and comparative effectiveness.
详细描述
Based on the operating procedures established by the Corrona Rheumatoid Arthritis (RA) Registry, the Psoriasis Registry will use a parallel structure based on a design and strategy developed by Corrona, LLC. This registry will be cooperatively managed by scientific, operational, and quality leaders at Corrona and medical leaders appointed by the National Psoriasis Foundation (NPF).
Investigators may enroll patients who have started on or switched to a systemic agent for psoriasis within the previous twelve months. Currently approved subcutaneous biologics are indicated for adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy. The currently approved intravenous biologic agent is indicated for adult patients with chronic severe plaque psoriasis who are candidates for systemic therapy, and when other systemic therapies are medically less appropriate. All patients will receive standard of care treatments prescribed by the investigator, in accordance with the FDA-approved drug labeling, and all treatment decisions are the sole responsibility of the investigator.
This study will be conducted at approximately 200 sites across North America. Sites are assessed and selected through interviews with potential investigators and a corresponding site feasibility survey that includes information on the investigator's qualifications, previous research experience, and the availability of support staff, sub-investigators, and patient population.
The Corrona Psoriasis Registry is a longitudinal, observational study; therefore, the duration is indefinite with no pre-determined stop date. The enrollment period is estimated to take approximately four years, and subjects will be followed for a minimum of eight years beginning from the time the subject is enrolled.
The design is a prospective, multicenter, observational registry for subjects with psoriasis. Longitudinal follow-up data is obtained via Corrona Questionnaires completed by both subjects and their treating dermatologists (also known as "Providers" for a Corrona registry study) every 6 months (+/- 30 days). The registry is designed to collect data on patient demographics, smoking history, disease duration, disease severity, disease activity, history of prior psoriasis treatment, comorbidities, hospitalizations, adverse events of special interest, medication use, and laboratory results.
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
- •ELIGIBILITY CRITERIA∗ To be eligible for enrollment into the CorEvitas Psoriasis Registry, a patient must satisfy all of the inclusion criteria and none of the
排除标准
- •listed below.
- •Inclusion Criteria:
- •The patient must:
- •Have been diagnosed with psoriasis by a dermatologist.
- •Be at least 18 years of age or older.
- •Be willing and able to provide written consent for participation in the registry.
- •Be willing and able to provide Personally Identifiable Information (PII) that includes the following types of personal information at a minimum: 1) Full Name and 2) Date of Birth.
- •Meet one of the following criteria.
- •Have started on or switched to a systemic psoriasis treatment within the previous 12 months†▲:
- •Exclusion Criteria:
- •1. Patient is participating in or planning to participate in a double-blind randomized of a psoriasis drug. Of note, concurrent participation in another observational registry or open-label Phase 3b/4 trial is not excluded.
研究组 & 干预措施
Psoriasis
Pts presenting to enrolling sites across the US are invited to enroll if eligible
结局指标
主要结局
Number of patients with adverse events (AEs) or serious adverse events (SAEs).
时间窗: A minimum of 8 years from last patient enrolled
Targeted events include malignancy, cardiovascular disease, serious infection, inflammatory bowel disease, gastrointestinal perforation, neurological events, hepatic events, and general serious adverse events. An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.
次要结局
- Disease burden: Psoriatic area and severity index (PASI)(every 6 months for 8 years)
- Disease burden: Investigators Global Assessment (IGA)(every 6 months for 8 years)
- Disease burden: Body surface area (BSA)(every 6 months for 8 years)
- Percentage of patients with history of comorbidities(time frame: at registry enrollment)
- Physician reported: Fitzpatrick skin type(time frame: every 6 months for 8 years)
- Patient reported: Pain, Fatigue, Itch score on Visual Analog Scale (VAS) (1-100)(time frame: every 6 months for 8 years)
- Patient reported: EuroQOL-5D-3L(time frame: every 6 months for 8 years)
- Patient reported: Dermatology Quality of Life index (DLQI)(time frame: every 6 months for 8 years)
- Patient reported: Work productivity and Activity Impairment (WPAI)(time frame: every 6 months for 8 years)