NCT04022525已完成不适用
Assessment of Leflunomide Efficacy and Hepatotoxicity in Patients With Rheumatoid Arthritis Through Pharmacokinetic and Genetic Approaches
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Detection of single nucleotide polymorphisms associated with response to the drug
研究概览
简要总结
The RA patients receiving leflunomide for more than one month, and not receiving other DMARDs (except hydroxychloroquine), will be enrolled to assess their disease activity. Blood samples will be collected for genetic studies and pharmacokinetic assay of the blood levels of the drug and its active metabolite.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Rheumatoid arthritis patients already receiving leflunomide with or without Hydroxychloroquine but without other Disease modifying agents
排除标准
- •Those diagnosed with other rheumatic diseases or Rheumatoid patients receiving disease modifying agents other than leflunomide
研究组 & 干预措施
leflunomide responsive vs non-responsive
干预措施: Leflunomide 20Mg Tab (Drug)
结局指标
主要结局
Detection of single nucleotide polymorphisms associated with response to the drug
时间窗: one -two years
SNPs associated with the response or adverse drug reactions will be detected and correlated with the ratio of leflunomide to its active metabolite
次要结局
未报告次要终点
研究者
Alaa Abdelkhalik Ahmed Mohamed
Principal Investigator
Assiut University
研究点 (1)
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