A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 542
- 主要终点
- The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.
研究概览
简要总结
To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.
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
- Triple (Participant, 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
- •Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
- •Has RA greater than or equal to 3 months and less than or equal to 2 years
排除标准
- •Received any previous treatment with MTX
- •Received any previous treatment with ETN or other tumour necrosis factor antagonist
研究组 & 干预措施
1a
Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
干预措施: Etanercept (Drug)
1a
Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
干预措施: Methotrexate (Drug)
1b
Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
干预措施: Etanercept (Drug)
1b
Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
干预措施: Methotrexate (Drug)
1b
Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
干预措施: Placebo (Drug)
2a
Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
干预措施: Etanercept (Drug)
2a
Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
干预措施: Methotrexate (Drug)
2a
Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
干预措施: Placebo (Drug)
2b
Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)
干预措施: Methotrexate (Drug)
结局指标
主要结局
The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.
时间窗: 12 months
Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.
Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.
时间窗: 12 months
The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.
次要结局
- Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death(12 and 24 months)