Prospective Post Marketing Surveillance To Evaluate The Safety And Efficacy Of Etanercept Under Usual Care Settings In Patients With Psoriatic Arthritis (Psa) Treated By Dermatologists
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 129
- 试验地点
- 1
- 主要终点
- Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
研究概览
简要总结
The purpose of this study is to evaluate the safety profile and the effectiveness of etanercept under usual care settings in patients with PsA treated by dermatologists.
详细描述
Non-interventional study: subjects to be selected according to the usual clinical practice of their physician
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
- •Clinical diagnosis of Psoriatic Arthritis
排除标准
- •Sepsis or risk for sepsis,
- •Acute infection,
- •Hypersensitive against Etanercept
研究组 & 干预措施
Patients with Psoriatic Arthritis
干预措施: etanercept (Drug)
结局指标
主要结局
Percentage of Participants With Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)
时间窗: Baseline up to Week 52
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was 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. Treatment-emergent are events between first dose of study drug and Week 52 (end of the observation period) that were absent before treatment or that worsened relative to pretreatment state. AEs included SAEs as well as non-serious AEs which occurred during the trial.
次要结局
- Change From Baseline in Percent Body Surface Area (BSA) Affected by Psoriasis at Week 52(Baseline, Week 52)
- Change From Baseline in Psoriasis Area and Severity Index (PASI) at Week 52(Baseline, Week 52)
- Change From Baseline in Physician Global Assessment of Disease Activity at Week 52(Baseline, Week 52)
- Change From Baseline in Patient Assessment of Itching at Week 52(Baseline, Week 52)
- Change From Baseline in Disease Activity Score Based on 28 Joints Count (DAS 28) at Week 52(Baseline, Week 52)
- Change From Baseline in Ritchie Index at Week 52(Baseline, Week 52)
- Number of Participants With Nail Involvement(Baseline, Week 12, 52)
- Change From Baseline in C-reactive Protein (CRP) at Week 52(Baseline, Week 52)
- Change From Baseline in Patient Assessment of Pain at Week 52(Baseline, Week 52)
- Change From Baseline in 12-Item Short Form Health Survey (SF-12) at Week 52(Baseline, Week 52)