NCT00969527已完成3 期
Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Catalysis SL
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Disease Activity Score (DAS 28 score) at week 12.
研究概览
简要总结
The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score will be assessed at the end of the study.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Treatment-naive subjects with recent onset rheumatoid arthritis
- •Signed informed consent
排除标准
- •Subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset
- •Subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis
结局指标
主要结局
Disease Activity Score (DAS 28 score) at week 12.
时间窗: 12 weeks
DAS 28=(0.56√NAD+ 0.28√NAT+0.7lnVSG+0.14EGE) where NAD: number of joints with pain; NAT: number of joints with increased volume; VSG: sedimentation rate of erythrocytes; EGE: Global assessment of disease by the patient on a visual analog scale (1 to 100 mm)
次要结局
- Number of patients with Adverse Events at week 12(12 weeks)
研究者
研究点 (2)
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