NCT01131910已完成2 期
Efficacy of TBE-vaccine to Patients With Rheumatic Disease Who Are Treated With Methotrexate and/or TNF-alfa Blocking Drugs
Sormland County Council, Sweden8 个研究点 分布在 2 个国家目标入组 68 人开始时间: 2010年5月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 8
- 主要终点
- Seroconversion rate
研究概览
简要总结
The investigators intend to check whether the efficacy of a TBE-vaccine is substantially deteriorated in patients with rheumatoid arthritis who are treated with drugs which suppress the immune system. The investigators aim to detect a difference of at least 10 % compared to healthy individuals (historical controls) in protection when analysed with serology. If the investigators detect a difference, the investigators will continue to explore whether protection can be achieved by additional doses
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
- •Rheumatoid arthritis treated with methotrexate and/or TNF-alfa blocking drugs
- •Interest to be vaccinated
- •Written consent
- •Age 18 years or more
排除标准
- •Previous TBE-infection
- •Previous Vaccination with TBE
- •Pregnancy
- •Breast feeding
- •Treatment with rituximab the last 9 months
- •Inability to follow study protocol
结局指标
主要结局
Seroconversion rate
时间窗: 1 year
The humoral response to TBE-vaccine
次要结局
未报告次要终点
研究者
研究点 (8)
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