NCT00455208Unknown1 期
Study Evaluating Cura-100 in Rheumatoid Arthritis and Osteoarthritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
研究概览
简要总结
The purpose of the study is to evaluate the safety and efficacy of Cura-100 in treating rheumatoid arthritis and osteoarthritis.
详细描述
This is the Phase I/II trial, which monitors both safety and efficacy of Cura-100 in subjects with rheumatoid arthritis and osteoarthritis at one clinical study center. The open-label clinical study will be used in the study. The study is expected to last for one and a half year after it has been officially started, which include recruitment, study treatment and follow-ups. The healthy volunteers are also included to study the safety of the intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having a diagnosis of rheumatoid arthritis and osteoarthritis at active stage
- •Able and willing to comply with study visits and procedures specified in this protocol for at least six months period
- •Able to understand and willing to sign and date the written informed consent form prior to admission of the study
- •Able and willing to provide adequate information for locator purposes
- •Able and willing to provide self evaluation information and diagnostic report of arthritis as required for efficacy evaluation
排除标准
- •Pregnant women
- •Over-weighted
- •Hypertension, or diabetes, or a history of cardiovascular disease or kidney disease, or serious skin allergy or other concurrent clinically significant illness or medical condition (other than arthritis) which, in the viewpoint of the study doctor, may put the subject at a possible risk for participation
- •Patients used biologic modifier therapy or currently taking immunosuppressive agents might be excluded
- •Unable to spend 3 hours for treatment at the study center
结局指标
主要结局
The primary outcome is remission of rheumatoid arthritis and osteoarthritis, which will be measured with ACR criteria.
次要结局
- The secondary outcome is the reduction in signs and symptoms of rheumatoid arthritis and osteoarthritis for a continuous three or six month period, measured with ACR20 and the change from baseline in HAQ.
研究者
研究点 (2)
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