NCT00650026Approved For Marketing不适用
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects With Active Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- Approved For Marketing
- 发起方
- Abbott
研究概览
简要总结
Multicenter Early Access Program of the Safety of Human Anti-TNF Monoclonal Antibody Adalimumab in Subjects with Active Rheumatoid Arthritis
研究设计
- 研究类型
- Expanded Access
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
- •Eighteen years or older
- •Females - post-menopausal for at least 1 year, surgically sterile or practicing an acceptable method of birth control
- •Females - negative pregnancy test at screening
- •Confirmed diagnosis of active RA >= 6 swollen joints and >= 9 tender joints
- •Met ACR criteria for diagnosis of RA for at least 3 months
- •Active RA defined by a DAS >= 3.2 at study entry
排除标准
- •Subject had prior treatment with cyclophosphamide or chlorambucil
- •Subjects previously treated with total lymphoid irradiation or anti-CD4 or CAMPATH 1H monoclonal antibodies resulting in CD4 lymphopenia
- •Prior treatment with intravenous immunoglobulin or investigational agent in with 30 days or 5 half-lives of adalimumab
- •Subject with history of cancer within the past 10 years other than resected basal cell or squamous cell carcinoma of the skin
研究者
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