An Observational Cohort Study to Evaluate Factors Affecting Prevalence of Fatty Liver Disease and Fibrosis and Factors Affecting Response to Treatment in Patients With Psoriasis
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Number of participants with liver fibrosis.
研究概览
简要总结
• Main objectives and outcome measures.
- Establish prevalence of and factors contributing to fatty liver disease and liver fibrosis in patients with psoriasis.
Fatty liver disease diagnosed via ultrasound. Liver fibrosis diagnosed by liver biopsy or non-invasive tests of fibrosis including transient elastography, ultrasound, serum markers of fibrosis including procollagen-3-N-terminal peptide (P3NP). 2. Evaluate non-invasive markers of liver fibrosis in the psoriasis population. Namely transient elastography, standard liver function tests and P3NP. 3. Evaluate the impact of psoriasis disease severity and comorbidities including metabolic syndrome on response to treatment in patients with psoriasis.
Data on co-morbid disease collected through questionnaires and review of medical records. Response to treatment assessed using psoriasis area and severity index (PASI) physician global assessment (PGA) and dermatology life quality index (DLQI).
- Study population: 380 patients with moderate to severe psoriasis will be prospectively recruited to the study.
- Chief investigator: Professor Jonathan Barker. Co-investigator: Professor Catherine Smith
- Sponsor/funding organization: Pfizer and Biomedical Research Centre (BRC) at Guys and St Thomas Hospitals Trust
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have given written informed consent
- •Psoriasis patients - chronic plaque-type psoriasis; PASI of 10 or above currently or in past.
- •18 yrs. of age
排除标准
- •Patients who have not given written informed consent
- •Patients under 18 yrs. of age
- •Patients with a PASI less than
- •Pregnant women
结局指标
主要结局
Number of participants with liver fibrosis.
时间窗: 12 months after enrollment
Liver fibrosis will be assessed by transient elastography and the use of standard liver function tests and other serum markers of fibrosis including P3NP. In a minority of cases fibrosis will be diagnosed by liver biopsy and evaluation of histology. Risk factors for the development of fibrosis including metabolic syndrome, alcohol and methotrexate use will be evaluated.
次要结局
- Number of participants with fatty liver disease diagnosed by ultrasound(Within 12 months of enrollment)