A Randomized, Open-label Study to Assess the Pharmacokinetics of Simvastatin and Methotrexate in Combination With Tocilizumab in Patients With Rheumatoid Arthritis.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 23
- 主要终点
- Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
研究概览
简要总结
This 2 arm study will investigate the pharmacokinetics of simvastatin and methotrexate in combination with tocilizumab to assess any potential drug interactions. Patients will be randomized to receive either tocilizumab (10mg/kg iv infusion on day 8) + methotrexate (10-25mg po /week) or tocilizumab + methotrexate + simvastatin (40mg po on days 1, 15 and 43). Blood samples will be taken for analysis at intervals up to day 44. The anticipated time on study treatment is <3 months, and the target sample size is <100 individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients, 18-75 years of age;
- •rheumatoid arthritis for >=6 months;
- •methotrexate for >=12 weeks prior to day 1 (stable at 10-25mg/week for 8 weeks).
排除标准
- •history of, or current inflammatory joint disease or rheumatic autoimmune disease other than RA;
- •concurrent treatment with any DMARD other than methotrexate;
- •prior treatment with tocilizumab.
研究组 & 干预措施
1
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
1
干预措施: Methotrexate (Drug)
1
干预措施: Simvastatin (Drug)
2
干预措施: tocilizumab [RoActemra/Actemra] (Drug)
2
干预措施: Methotrexate (Drug)
结局指标
主要结局
Pharmacokinetic parameters for simvastatin and metabolite, and methotrexate and metabolite.
时间窗: Days 1, 15 and 43
次要结局
- Pharmacokinetic parameters for tocilizumab.(Days 11, 22, 29 and 36.)
- CRP, IL-6, sIL-6R changes(Throughout study)
- AEs, laboratory parameters.(Throughout study)