NCT04454034Unknown不适用
Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- ACR70 remission
研究概览
简要总结
Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is an important method to save the function of joint in the treatment of refractory RA. The clinical trial is to study the value of AS combine with DMARDs in the early stage of refractory RA.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010 ACR/EULAR（European League Against Rheumatism） RA classification criteria.
- •The age is more than 18 years old and less than 60 years old.
- •They received stable traditional DMARDs (including Chrysopidae, leflunomide, sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal antibodies) for at least 6 months.
- •The disease is still in the active stage, which means the disease activity score (DAS28) is more than 3.2, and the elbow joint function is obviously limited.
- •The patient agreed to undergo arthroscopic synovectomy.
- •No contraindications were found.
排除标准
- •The disease is in remission.
- •The patient has contraindications.
- •Arthroscopic synovectomy was performed in different patients.
结局指标
主要结局
ACR70 remission
时间窗: 6 months after surgery
the percent of patients who meet ACR70 remission
次要结局
- Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)(1,3,6 and 12 months after surgery)
- swollen joint count(1,3,6 and 12 months after surgery)
- tender joint count(1,3,6 and 12 months after surgery)
研究者
研究点 (1)
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