The Effect of Tocilizumab on the Cellular Immune Response to Seasonal Influnza Vaccine in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Cellular response
研究概览
简要总结
Patients with rheumatoid arthritis (RA) are prone to respiratory infections and therefore recommmended to receive vaccination against seasonal influenza. We and others have shown a relatively preserved humoral response to vaccination in RA patients. However, the cellular response as well as the effect of biologics such as tocilizumab on the cellular response has not been weel studied. The purpose of this study is the evaluate the effect of tocilizumab on the cellular immune response to influenza vaccine in patients with RA in comparison with healthy controls
详细描述
Inclusion criteria :
- RA patients
- Above the age of 18
- Treated with tocilizumab at least 3 months
Exclusion criteria:
-egg allergy
Design of the study :
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Rheumatoid Arthritis patients treated with Tocilizumab for at least 3 months
- •Above the age of 18
排除标准
- •Allergy to eggs
研究组 & 干预措施
Seasonal influenza vaccine in tocilizumab treated RA patients
RA patients treated with tocilizumab
干预措施: Seasonal influenza vaccine (Biological)
Seasonal influenza vaccine to Healthy controls
Healthy controls will be vaccinated against seasonal influenza
干预措施: Seasonal influenza vaccine (Biological)
结局指标
主要结局
Cellular response
时间窗: 4 weeks
As described in the study design using the Interferin gamma and granzyme B levels
次要结局
- Humoral response(4 weeks)