The Difference of Circulating Endothelial-derived and Platelet-derived Microparticles in Patients With Psoriasis Successfully Treated With Stelara(Ustekinumab)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- The difference of CD41a and CD31 positive microparticles in patients with severe psoriasis before and after ustekinumab treatment.
研究概览
简要总结
Background: Psoriasis, a common inflammatory disease, is associated with atherosclerotic vascular diseases, including stroke, myocardial infarction, and impaired microcirculations, among which circulating microparticles play an important role. In severe psoriasis, there are increased endothelial- and platelet- microparticles that are reduced by TNF-α blockers in parallel with clinical improvement. However, whether Stelara(ustekinumab) treatment would decrease the level of microparticles remains unknown.
Objective: The investigators will evaluate the level of microparticles among normal control, severe psoriasis before and 4 months after ustekinumab treatment.
详细描述
Methods: The investigators will recruit 50 patients with severe psoriasis who received ustekinumab and 50 control subjects without psoriasis from August 2014 to July 2016. Concentrations of microparticles with expression for surface markers (Annexin V, CD31, and CD41a) will be measured in peripheral blood using flow cytometry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with severe psoriasis who receive ustekinumab treatment.
- •Patients in the control group are examined thoroughly to make sure no psoriatic lesions by two dermatologists. Age, sex, lipid profiles, and blood pressure are recorded for all subjects.
排除标准
- •The psoriatic patients and healthy controls who have pregnancy or infection (such as tuberculosis or sepsis) are excluded.
研究组 & 干预措施
single-arm study
50 patients with severe psoriasis who received Stelara(ustekinumab) at 0 and 1 month. The investigators check microparticles level at baseline and 4 months later.
50 patients without psoriasis: the microparticles are checked at baseline.
干预措施: Ustekinumab (Drug)
结局指标
主要结局
The difference of CD41a and CD31 positive microparticles in patients with severe psoriasis before and after ustekinumab treatment.
时间窗: The levels of CD41a and CD31 positive microparticles are checked in patients with psoriasis before and 4 months after ustekinumab.
次要结局
- The difference of CD41a and CD31 positive microparticles between normal control and patients with severe psoriasis(Patients with severe psoriasis: microparticles are checked at baseline. Control group: microparticles are checked at baseline.)