jRCTs031230070招募中不适用
Multicenter prospective study of attenuated live vaccines for patients using TNF-alfa inhibitors
未提供0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 主要终点
- Seropositivity rate of measles
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 1age old over 至 No limit（—）
- 性别
- All
入选标准
- •(1) Age >= 1 year.
- •(2) Patients using TNF-alfa inhibitors
- •(3) Negative or borderline antibody (EIA-IgG < 4.0) against either measles, rubella, varicella or mumps
- •(4) CD4 cells >= 500/mm3
- •PHA stimulation index >= 101.6
- •Serum IgG >= 300mg/dL
- •(5) PSL<=1mg/day or <=2mg/2days
- •(6) Disease activity is stable for more than 6 months
排除标准
- •(1) Patients using other biological agents.
- •(2) Patients with hematological disease or after bone marrow transplantation.
- •(3) High disease activity.
- •(4) Patients under immunoglobulin replacement.
- •(5) Patients who are planned to receive inactivated VZV vaccine (they cannot receive live varicella vaccine, but can receive MR and mumps vaccine).
结局指标
主要结局
Seropositivity rate of measles
Seropositivity rate after MR vaccination
Seropositivity rate of rubella
Seropositivity rate after MR vaccination
Seropositivity rate of varicella
Seropositivity rate after varicella vaccination
Seropositivity rate of mumps
Seropositivity rate after mumps vaccination
次要结局
未报告次要终点
研究者
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