NCT00649922已完成4 期
Assessment of the Effect of Adalimumab on Response to Influenza Virus and Pneumococcal Vaccines in Subjects With Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 226
- 主要终点
- Blood samples for Influenza A & B antibody Assay
研究概览
简要总结
To evaluate the immunogeneicity of the Influenza virus and standard 23-valent pneumococcal virus in subject with RA receiving adalimumab or placebo
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male/Females at least 20 years of age.
- •Females post-menopausal for at least 1 year, surgically sterile, or practicing acceptable methods of birth control.
- •Females have a negative pregnancy test at screening.
- •Diagnosis of RA and met ACR criteria.
- •Must discontinue any TNF at least 2 months prior to baseline.
- •In condition of general good health.
排除标准
- •History of significant sensitivity to any drug; clinically significant drug or alcohol abuse within the past year; active infection with Listeria or TB; lymphoma or leukemia; sickle-cell disease, splenectomy, other malignancy within 5 years with the exception of successfully treated non-metastatic basal cell or squamous cell carcinoma of skin or localized carcinoma in situ of the cervix.
- •History of current acute inflammatory joint disease.
- •Use of TAMIFLU or Symmetrel within 3 months of study drug administration.
- •Recent (3 month) history of influenza or pneumococcal bacterial infection.
- •Known positive human immunodeficiency virus (HIV) status.
- •Positive hepatitis B or hepatitis C virus.
- •Positive PPD >5 mm.
- •Chest x-ray with calcified granulomas and/or pleural scarring or significant abnormalities.
结局指标
主要结局
Blood samples for Influenza A & B antibody Assay
时间窗: Baseline (Day 1), Day 36 or premature discontinuation
Blood Samples for Pneumococcal Antibody Assay
时间窗: Baseline (Day 1), Day 36 or premature discontinuation
次要结局
- Laboratory assessments(Screening, Week 15, Day 36, Month 3 and Month 6)
- Vitals signs(Screening - Month 6)
- Adverse events(Screening - Month 6)
研究者
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