Pharmacogenomics Study on Treatment of Psoriasis Vulgaris by Methotrexate
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- disease control rate
研究概览
简要总结
To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.
详细描述
Previous studies have indicated that the gene mutations of absorption distribution metabolism and drug target may affect the efficacy of Methotrexate in vivo.To investigate the influence of genetic factors on the curative effect , to find the relationships between genetic variants and the response of Methotrexate to treatment of Psoriasis Vulgaris.Investigators analyzed the various levels of genetic factors, including: 1.To analysis the key gene variants which associated with ADME(absorption, distribution, metabolism and excretion) affect the efficacy of Methotrexate; 2.Direct full genetic sequencing of MHC genes, to explore the genetic variations of efficacy and side effects; 3. Direct sequencing of all exons in the gene in the patients of the response of serious and effectively, to explores the rare genetic variation may cause deterioration of treatment by Methotrexate.
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
- 否
入选标准
- •Diagnosed according to Classification criteria for Psoriasis vulgaris
- •Patients aged 18 to 70 years (to the date of screening)
- •Not treatment in the Topical corticosteroids, Biologicals agents or Tretinoin cream
- •Phototherapy nearly one months before enrolled
- •Total bilirubin < 1.5 x ULN, AST(SGOT)/ALT(SGPT) <2.5 x ULN, if not liver metastases < 5 x ULN, if known liver metastases, Creatinine clearance <1.5 x ULN
- •Understanding the whole process of the study, voluntary participation and signed the informed consent
排除标准
- •Pregnant women, ready to pregnant or lactating women
- •Have a serious heart, lung, kidney and other vital organs and endocrine system lesions and the history
- •Patients is liver function abnormal persons (ALT above the center laboratory normal limit) or hepatitis b patient grain carriers
- •Patients with chronic diarrhea, or peptic ulcer nearly 1 year
- •Patients suffering from malignant tumor
- •Patients suffering from acute and chronic infectious diseases
- •Mental disorders, history of alcohol abuse, drug or other substance abuse
- •Other cases which researchers believe that can not enroll
研究组 & 干预措施
single-arm
intervention: open registry, non-randomized, single-arm trial.Methotrexate:2.5mg per piece, oral.
干预措施: Methotrexate (Drug)
结局指标
主要结局
disease control rate
时间窗: 8 weeks after the first treatment
次要结局
未报告次要终点
研究者
Yijing He
Associate Professor
Central South University