Effects of Different Anti-rheumatic Treatments of Arthritis on Antibody Response Following Pneumococcal Vaccination Using Prevenar®
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Region Skane
- 入组人数
- 505
- 试验地点
- 1
- 主要终点
- Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups.
研究概览
简要总结
Previous studies have analyzed serological responses following pneumococcal vaccination using 23-valent vaccination (Pneumovax) in Rheumatoid Arthritis (RA) patients that were on different therapeutic modalities including TNF-blockers and methotrexate. The results have shown that serological response was significantly reduced in RA patients receiving methotrexate compared to those receiving TNF-blockers.
In contrast when using polypeptide immunisation (influenza vaccine) we found that anti-TNF significantly impaired the serological response compared to the methotrexate treated RA patients. The aim of this study is to analyze serological responses after Prevenar vaccination in patients with chronic arthritis and to study the impact of different treatment modalities on serological responses.
It will be of interest to see if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.
详细描述
Background: Previous studies have analyzed serological responses following pneumococcal vaccination using 23-valent vaccination (Pneumovax) in Rheumatoid Arthritis (RA) patients that were on different therapeutic modalities including TNF-blockers and methotrexate. The results have shown that serological response was significantly reduced in RA patients receiving methotrexate compared to those receiving TNF-blockers (Rheumatology (Oxford) 2006 Jan; 45(1):106-11).
In contrast when using polypeptide immunisation (influenza vaccine) we found that anti-TNF significantly impaired the serological response compared to the methotrexate treated RA patients.
The aim of this study is to analyze serological responses after PREVENAR vaccination in patients with RA or spondylarthropathy and to study the impact of different treatment modalities on serological responses.
It will be of interest to see if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.
Study design:
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
- •Age > 18 years
- •Clinical diagnosis of RA or spondylarthropathy
排除标准
- •Pregnancy
- •Has received pneumococcal vaccination within 5 years
研究组 & 干预措施
Prevenar vaccine
all participants are immunized with a dose of pneumococcal conjugate vaccine
干预措施: Prevenar vaccination (Biological)
结局指标
主要结局
Serological responses to at least 2 pneumococcal serotypes included in Prevenar vaccine between different treatment groups.
时间窗: 2009
次要结局
- to analyse if the result is different compared to the one seen after immunizing with 23-valent nonconjugated pneumococcal polysaccharide vaccine.(2009)