Observational Post-Marketing Safety Surveillance Registry of Enbrel (Etanercept) for Treatment of Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 2,511
- 主要终点
- Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events
研究概览
简要总结
This is an observational safety study tracking psoriasis patients on etanercept (Enbrel) for 5 years.
详细描述
This is a prospective, multi-center, observational surveillance registry to evaluate data on the long-term safety of etanercept (Enbrel) use in the treatment of psoriasis.
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
- •Patients with plaque psoriasis
排除标准
- •Prior exposure to any tumor necrosis factor (TNF)-inhibitor
- •Patients for whom Enbrel is contraindicated
- •Patients currently enrolled in or has not yet completed at least 30 days since ending other investigational drug study.
研究组 & 干预措施
Etanercept
Participants received etanercept (Enbrel) treatment at the dose and regimen determined by the investigator and were evaluated for up to 5 years at 6-month intervals. During this period, participants may have discontinued etanercept therapy, may have switched to another anti-psoriatic therapy, may have used etanercept in combination with other anti-psoriatic therapies, or may have discontinued any or all antipsoriatic treatments.
干预措施: Etanercept (Drug)
结局指标
主要结局
Five-year Cumulative Incidence of Serious Adverse Events and Serious Infectious Events
时间窗: 5 years
A serious adverse event (SAE), including a serious infectious event (SIE), is defined as one that suggests a significant hazard or side effect, regardless of the investigator or sponsor's opinion on the relationship to a drug product. This includes, but may not be limited to, any event that (at any dose) is fatal, life threatening, requires inpatient hospitalization that includes a minimum of an overnight stay or prolongation of existing hospitalization, is a persistent or significant disability/incapacity, or is a congenital anomaly/birth defect. Cumulative incidences were calculated using Kaplan-Meier methodology for all participants who received at least 1 registry dose of etanercept. For SAEs and SIEs, time to event was re-defined from calendar time to cumulative time up to the event, excluding time intervals and events when the participant was not on etanercept treatment (ie, based on etenercept exposure time).
次要结局
- Five-year Cumulative Incidence for Events of Medical Interest (EMIs)(5 years)
- Percentage of Participants With a Static Physician's Global Assessment (sPGA) of Psoriasis Score of 0 (Clear) or 1 (Almost Clear)(Baseline and at 3 and 5 years)
- Percentage of Participants With a Patient's Global Assessment of Psoriasis Score of 0 or 1(Baseline and at 3 and 5 years)
- Euroqol-5D (EQ-5D) Visual Analog Scale (VAS)(Baseline, Year 3 and Year 5)
- Healthcare Resource Use(Baseline, Year 3 and Year 5)
- Percentage of Participants With a Dermatology Life Quality Index (DLQI) Response(Baseline, Year 3 and Year 5)
- Euroqol-5D (EQ-5D) Total Score(Baseline, Year 3 and Year 5)
- Work Productivity and Activity Impairment (WPAI)(Baseline, Year 3 and Year 5)
- Percentage of Body Surface Area Affected by Psoriasis(Baseline, Year 3 and Year 5)