ACTRN12609000078257终止2 期
A mulit-centre, long term follow-up, open label trial to assess the efficacy and safety of Cpn10 in subjects with rheumatoid arthritis (Protocol number CBIO2008-01)
适应症
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- CBio Limited
- 入组人数
- 150
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
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1. Participants must have completed Protocol CBIO2007-01
- •2. In general good health other than RA
- •3. For females a negative pregnancy test at screening, unless surgically sterile or at least 2 years post menopausal
- •4. Use of a medically reliable method of contraception throughout the study
- •5. Provide written informed consent
排除标准
- •1. History of allergic or anaphylactic reactions to Cpn10
- •2. Active or latent bacterial, fungal, viral or atypical mycobacterial infections at the time of screening that the investigator deems clinically significant
- •3. Females who are lactating or pregnant
- •4. Significant concurrent medical diseases including metabolic, haematological, cardiac, renal, hepatic, infectious, psychiatric or gastrointestinal conditions which in the opinion of the investigator places the study participant at an unacceptable risk for participation in the study
研究者
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