Effects of TNF-alpha Antagonism (Etanercept) in Patients With the Metabolic Syndrome and Psoriasis
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome
研究概览
简要总结
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol.
详细描述
People with psoriasis have significantly higher rates of obesity, diabetes, heart failure and high blood pressure than the general public. The purpose of this study is to determine how substances produced in the fat (inflammatory markers) relate to the risk of heart disease in people with the metabolic syndrome and psoriasis. People with metabolic syndrome have insulin resistance, increased waist size, high blood pressure, or high cholesterol. Insulin resistance means that the body does not respond well to the insulin in your blood. Therefore, both blood levels of insulin and glucose (sugar) are high.
This causes inflammation (irritation) in the body. Inflammation can cause an unhealthy response in your body and blood vessels, and can lead to blockages in the heart and other vessels.
TNF-alpha is a substance made by fat and inflammatory cells that helps cause inflammatory reactions. TNF-alpha is thought to be important in causing psoriasis. The drug Etanercept blocks TNF-alpha's actions, and has been approved by the Food and Drug Administration (FDA) for the treatment of psoriasis. We think that Etanercept may also reduce the inflammation associated with metabolic syndrome and decrease the risk of heart disease. All subjects in this study will receive etanercept.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
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
- •Subject willing and able to give informed consent.
- •Adult patients with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
- •PASI > 10 and BSA affected with psoriasis >
- •Abdominal obesity defined by waist hip ratio > 0.90 for men and > 0.85 for women and BMI ³ 30 kg/m2
排除标准
- •On insulin or other diabetes (anti-hyperglycemic) medication
- •Congestive Heart Failure
- •Heart Attack, Stroke or Transient Ischemic Attack in last 3 months
- •Unstable angina
- •Pulmonary disease requiring oxygen
- •SLE, optic neuritis, transverse myelitis, epilepsy
- •Positive PPD
- •Scheduled for upcoming surgery
- •Known immunosuppression (for example, HIV)
- •Known autoimmune disease
- •Hepatitis B or Hepatitis C
- •Pregnant or nursing
- •Renal insufficiency (Creatinine >1.5)
- •Latex allergy
- •Use of live vaccination in past 90 days
- •Organ transplantation
- •History of severe infection
- •History of malignancy (except cured non-melanoma skin cancer)
研究组 & 干预措施
Etanercept
Etanercept
干预措施: Etanercept (Drug)
结局指标
主要结局
Change in CRP Levels From Baseline to 6 Months of Treatment in Subjects With Psoriasis and Metabolic Syndrome
时间窗: 6 months
Analyzing the difference in C reactive protein levels from baseline to month 6 in subjects with Psoriasis and Metabolic Syndrome
次要结局
- Change in Plasma Glucose in Subjects With Psoriasis and Metabolic Syndrome(6 months)
- Change of Endothelial Function by Measurement of Flow-mediated Vasodilation Using the Reactive Hyperemia Index (RHI) in 6 Months(6 months)
- Change in the Safety and Tolerability of Etanercept in Patients With Psoriasis and Metabolic Syndrome Over a 6-month Period.(6 months)
研究者
Alexandra Kimball
Director, Clinical Unit for Research Trials in Skin
Massachusetts General Hospital