NCT00264147已完成2 期
A Randomized, Placebo-Controlled, Double-Blind, Multicenter, Parallel-Group, 12-Week Study to Assess the Clinically Effective Dose Range of Etoricoxib and to Assess Its Safety and Tolerability in Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 761
- 主要终点
- Proportion of Patients Who Met the ACR20 Responder Index Criteria
研究概览
简要总结
To assess the clinically active dose range of study medication in the treatment of patients with rheumatoid arthritis.
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
- Double (Participant, Investigator)
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
- •Patient with diagnosed rheumatoid arthritis (RA) for at least 6 months prior who is otherwise judged to be in general good health and who is currently taking nonsteroidal anti-inflammatory drugs (NSAIDS) to treat his/her RA symptoms
- •Patient will need to stop taking these medications in order to participate, but can continue taking his/her other anti-rheumatic medications as long as they have been stable for certain periods of time
排除标准
- •Patients with a disease or medical condition(s) that could worsen or interfere with the evaluation of the effectiveness of study medication are not allowed to participate
研究组 & 干预措施
Period I: 1
Experimental
etoricoxib
干预措施: etoricoxib (Drug)
Period I: 2
Experimental
etoricoxib
干预措施: etoricoxib (Drug)
Period I: 3
Experimental
etoricoxib
干预措施: etoricoxib (Drug)
Period I: 4
Experimental
etoricoxib
干预措施: etoricoxib (Drug)
Period II: 1
Experimental
etoricoxib
干预措施: etoricoxib (Drug)
结局指标
主要结局
Proportion of Patients Who Met the ACR20 Responder Index Criteria
时间窗: 12 weeks
Proportion of Patients Who Met the American College of Rheumatology Response Index (20%) Criteria (ACR20) (Based on the Time-Weighted Average Responses of the 12-Week Treatment I Period and Completed the Treatment I Period) (All Patients-Treated Population)
次要结局
- Tender Joint Count (Out of 68 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)(Time-weighted average change from baseline across Weeks 2, 7, and 12)
- Investigator Global Assessment of Disease Activity (0- to 4-Likert Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)(Time-weighted average change from baseline across Weeks 2, 7, and 12)
- Swollen Joint Count (Out of 66 Joints) Time-Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment Period (All Patients-Treated Population)(Time-weighted average change from baseline across Weeks 2, 7, and 12)
- Patient Global Assessment of Pain (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)(Time-weighted average change from baseline across Weeks 2, 7, and 12)
- Patient Global Assessment of Disease Activity (0- to 100-mm Visual Analog Scale) Time Weighted Average Change From Baseline (Flare/Randomization Visit) in the 12-Week Treatment I Period (All Patients-Treated Population)(Time-weighted average change from baseline across Weeks 2, 7, and 12)
研究者
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