NL-OMON30739尚未招募不适用
Safety and efficacy of vaccination with T cell-dependent and T cell-independent primary and recall antigens in patients with rheumatoid arthritis treated with anti TNF-* antibodies (adalimumab) or anti B cell therapy (Rituximab). - SEVRA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •- RA diagnosed according to the revised 1987 criteria of the American College of Rheumatology (ACR) for at least 3 months
- •- Age 18-85 years
- •-Eligible for anti-TNF * or Rituximab therapy (according to the Dutch guidelines)
排除标准
- •- Pregnancy
- •- Breastfeeding
- •- Therapy within the previous 60 days with:
- •*any experimental drug
- •*alkylating agents, e.g. cyclophosphamide, chlorambucil
- •*monoclonal antibodies (including infliximab and etanercept)
- •*growth factors
- •*other cytokines
- •- A positive PPD skin test (> 4 mm induration)
- •- HIV infection
- •- History of severe allergic or anaphylactic reactions to vaccines
- •- Vaccination with KLH, Pneumovax, Meningovax, Polio or tetanus toxoid in the past 12 months
- •- Fever (orally measured > 38 °C), chronic infections or infections requiring anti-microbial therapy
- •- Manifest cardiac failure (stage III or IV according to NYHA classification)
- •- Progressive fatal disease/terminal illness
研究者
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