NCT00279734已完成1 期
An Exploratory Study to Evaluate the Effect of Abatacept (BMS-188667) on the Antibody Response Following Tetanus Toxoid and 23-Valent Pneumococcal Vaccinations in Healthy Subjects
Bristol-Myers Squibb3 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2004年8月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
研究概览
简要总结
Study to assess the ability of healthy subjects to build anitbodies to tetanus and pneumococcal vaccines after receiving a single intravenous dose of Abatacept, a drug which is being developed for the treatment of Rheumatoid Arthritis and which can affect the immune system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Subjects
- •Body Weight between 60 and 100 kg.
- •Males and Females must be using adequate contraceptive methods during study and for 10 weeks after dose of study mediciation.
排除标准
- •Females who are prgnant or breastfeeding
- •History of autoimmune disorder, immunodeficiency, or infection within past 3 months.
- •Active TB requiring treatment within the previous 3 years.
- •Positive breast cancer screen, PPD test.
- •Vaccination with tetanus or pneumococcal vaccine within 5 years.
- •Vaccination with any live vaccine within 4 weeks.
- •History of drug or alcohol abuse.
- •Any significant allergy.
研究组 & 干预措施
Group 1
Experimental
干预措施: Tetanus + pnemococcal vaccines alone (Drug)
Group 2
Active Comparator
干预措施: Abatacept + Vaccines (Drug)
Group 3
Active Comparator
干预措施: Abatacept + Vaccines (Drug)
Group 4
Active Comparator
干预措施: Abatacept + Vaccines (Drug)
结局指标
主要结局
Assess effect of single 750mg dose of Abatacept on antibody response to tetanus toxioid and 23-valent pneumococcal vaccines.
次要结局
- Assess safety and tolerability of Abatacept given in conjunction with tetanus toxoid and 23-valent pneumococcal vaccines.
研究者
研究点 (3)
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