A Randomized, Open-Label Study in the Asia-Pacific Region Comparing the Safety and Efficacy of Etanercept With Usual DMARD Therapy in Subjects With Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 主要终点
- Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks
研究概览
简要总结
The purpose of this study is to compare the efficacy of etanercept with usual disease-modifying anti-rheumatic drug (DMARD) therapy in the treatment of moderate to severe rheumatoid arthritis (RA) over 16 weeks in the Asia Pacific region.
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
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of RA
- •Currently receiving an adequate dose of methotrexate (MTX) for treatment of RA
- •Active RA at time of screening and baseline
排除标准
- •Previous or current treatment with etanercept (ETN), other tumor necrosis factor-alpha inhibitors, or other biologic agents
- •Concurrent treatment with a DMARD, other than MTX, at screening
- •Receipt of any DMARD, other than MTX, within 3 months before screening
研究组 & 干预措施
1
Etanercept + Methotrexate
干预措施: Etanercept , Methotrexate (Drug)
2
DMARD therapy Methotrexate + Sulfasalazine/Hydroxychloroquine/Leflunomide
干预措施: Methotrexate; sulfasalazine; hydroxychloroquine;leflunomide (Drug)
结局指标
主要结局
Change From Baseline in Adjusted Mean of American College of Rheumatology Response (ACR-N) Area Under Curve (AUC) Over 16 Weeks
时间窗: 16 weeks
ACR-N = the lowest of 3 values (percent change in the number of swollen joints, percent change in the number of tender joints, and median of the other 5 measures in the ACR core data set). Negative numbers indicate worsening. The ACR-N AUC was calculated using the trapezoidal rule as the ACR-N multiplied by the duration of the assessment period (in weeks) and was presented as %-weeks.
次要结局
- Percentage of Participants Achieving ACR 20, 50, and 70 Responses(Week 16)
- Percentage of Participants Achieving DAS28 <3.2 (Low Disease Activity) and <2.6 (Remission)(Week 16)
- Percent Change From Baseline in DAS28 at Week 16(Week 16)
- Percentage of Participants Achieving European League Against Rheumatism (EULAR) Moderate or Good Response(Week 16)
- Percentage of Participants With DAS28 Improvement of ≥0.6 and ≥1.2(Week 16)
- Percent Change From Baseline in Painful and Swollen Joint Counts(Week 2, 4, 8, 12, 16)
- Percent Change From Baseline in Physician And Subject Global Assessments(Week 2, 4, 8, 12, 16)
- Percent Change From Baseline in Duration (Minutes) of Morning Stiffness(Week 2, 4, 8, 12, 16)
- Percent Change From Baseline in General Health, Pain, and Fatigue, Visual Analog Scales(Week 2, 4, 8, 12, 16)