Comparison of Lower Dosage of Etoricoxib Versus Aceclofenac in the Treatment of Patients With Rheumatoid Arthritis: A Single-center, Parallel-group, Randomized Controlled Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 主要终点
- American College of Rheumatology 20% improvement criteria (ACR20)
研究概览
简要总结
Comparison of lower dosage etoricoxib (60 mg daily) with aceclofenac (100 mg bid) for their efficacy and safety in the treatment of rheumatoid arthritis (RA).
详细描述
This was a single medical center, parallel-group, randomized controlled trial, which conducted for eight weeks. In this study, 40 patients of RA were randomly assigned to two different treatment groups (etoricoxib and aceclofenac), and 20 patients were enrolled for each group. In addition to baseline data collection, objective assessment tools were used to evaluate for efficacy and safety. The primary endpoint was American College of Rheumatology 20% improvement criteria (ACR20) , secondary endpoints were the ACR 50,70, disease activity score 28 (DAS 28), European League Against Rheumatism (EULAR) response criteria, the number of tender and swollen joints, physician's global assessment, patient's global assessment, pain scores, the short form health survey (SF-36) health Questionnaire and etc. In addition, all adverse reactions were recorded and all the results were analyzed in the intention to treat (ITT) manner.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis as Rheumatoid Arthritis
排除标准
- •Pregnant or breast-feeding women.
- •Chemotherapy or radiation therapy in cancer patients
研究组 & 干预措施
Etoricoxib
Etoricoxib 60 mg QD
干预措施: Etoricoxib (Drug)
Aceclofenac
Aceclofenac 100 mg BID
干预措施: Aceclofenac (Drug)
结局指标
主要结局
American College of Rheumatology 20% improvement criteria (ACR20)
时间窗: week 0, week 8
The investigators use ACR20 to compared the difference between the week 8 and week 0
次要结局
- American College of Rheumatology 50% improvement criteria (ACR50)(week 0, week 8)
- American College of Rheumatology 70% improvement criteria (ACR70)(week 0, week 8)
- Disease activity score 28 (DAS28)(week 0, week 8)
- Physician's global assessment (PhGA)(week 0, week 8)
- Patient's global assessment (PGA)(week 0, week 8)
- European League Against Rheumatism (EULAR) response criteria(week 0, week 8)
- The number of tender and swollen joints(week 0, week 8)
- Visual Analog Scale for pain (VAS)(week 0, week 8)
- Quality of life by SF-36(week 0, week 8)
研究者
Cheng-Chung Wei
Professor
Chung Shan Medical University