NCT00565409已完成4 期
A Randomized, Double-Blind Study Comparing the Safety & Efficacy of Once-Weekly Etanercept 50 mg, Etanercept 25 mg, & Placebo in Combination With Methotrexate in Subjects With Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 834
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88
研究概览
简要总结
To compare the efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with that of methotrexate monotherapy in the treatment of rheumatoid arthritis over 88 weeks.
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 (Care Provider, Investigator, Outcomes Assessor)
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 rheumatoid arthritis.
- •Currently receiving an optimal dose of oral Methotrexate (MTX)(at least 15 mg/week but no more than 25 mg/week) for the treatment of rheumatoid arthritis.
- •Active rheumatoid arthritis at the time of screening.
排除标准
- •Previous or current treatment with etanercept, other tumor necrosis factor-alpha (TNF) inhibitors, or other biologic agents.
- •Concurrent treatment with any disease-modifying anti-rheumatoid drugs (DMARD), other than MTX within 28 days before baseline.
- •Concurrent treatment with more than 1 non-steroid anti-inflammatory drug (NSAID) at baseline.
研究组 & 干预措施
1
Active Comparator
干预措施: Etanercept (Drug)
1
Active Comparator
干预措施: Methotrexate (Drug)
2
Active Comparator
干预措施: Etanercept (Drug)
2
Active Comparator
干预措施: Methotrexate (Drug)
3
Placebo Comparator
干预措施: Placebo (Drug)
3
Placebo Comparator
干预措施: Methotrexate (Drug)
结局指标
主要结局
Percentage of Participants Achieving 28 Joint Disease Activity Score (DAS28) Less Than or Equal to (≤) 3.2 at Week 88
时间窗: Week 88
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joint count (less than \[\<\]20 percent \[%\] missing SJC or PJC was prorated), erythrocyte sedimentation rate (ESR) (millimeters per hour \[mm/hour\]) and Patient's General Health Visual Analog Scale (VAS). VAS is a line 0-100 millimeters (mm) in length; ranged from 0 (very well)-100mm (extremely bad). Participants placed a mark indicating their health over the previous 2-3 weeks. Higher scores indicated greater affectation due to disease activity. DAS28 ≤ 3.2 units equals (=) low disease activity.
次要结局
- Change From Week 36 in the PGA Score at Weeks 40, 48, 56, 64, 72, 80 and 88(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Change From Baseline in DAS28 at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- Change From Baseline in Prorated Swollen Joint Count at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- Change From Week 36 in Prorated Swollen Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88(Week 36, Weeks 40, 48, 56, 64, 72, 80 and 88)
- Change From Week 36 in Painful Joint Count at Weeks 40, 48, 56, 64, 72, 80 and 88(Weeks 36 40, 48, 56, 64, 72, 80 and 88)
- Change From Week 36 in PtGA of Arthritis Pain at Weeks 40, 48, 56, 64, 72, 80, 88(Weeks 36, 40, 48, 56, 64, 72, 80, 88)
- Change From Baseline in Duration of Morning Stiffness at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- Percentage of Participants With an ACR50 Response at Weeks 4, 8, 12, 20, 28 and 36(Weeks 4, 8, 12, 20, 28 and 36)
- Change From Week 36 in DAS28 at Weeks 40, 48, 56, 64, 72, 80 and 88(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Change From Baseline in Patient's Global Assessment (PtGA) of Arthritis Pain at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- Duration of Morning Stiffness at Week 36(Week 36)
- Change From Baseline in Pain at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- Pain at Week 36(Week 36)
- Change From Week 36 in Pain at Weeks 40, 48, 56, 64, 72, 80 and 88(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Percentage of Participants Achieving an Acceptable State on the PASS at Week 36 and Weeks 64 and 88(Weeks 36, 64 and 88)
- Percentage of Participants Achieving DAS28 Low Disease Activity or Remission at Baseline, Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28, 36)
- Time to Loss of Low Disease Activity DAS28(Week 36 up to Week 88)
- Painful Joint Count at Week 36(Week 36)
- Percentage of Participants With an American College of Rheumatology 20 Percent (%) (ACR20) Response at Weeks 4, 8, 12, 20, 28 and 36(Weeks 4, 8, 12, 20, 28 and 36)
- Percentage of Participants With an ACR50 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Percentage of Participants Achieving DAS28 Low Disease Activity or Remission(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Time to Loss of Low Disease Activity DAS28 and a Change of ≥ 0.6 Units in the DAS28(Week 36 up to Week 88)
- Proportion of Time Participants Had Low Disease Activity DAS28 Week 36 to Week 88(Week 36 up to Week 88)
- Prorated Swollen Joint Count at Week 36(Week 36)
- Change From Baseline in the Painful Joint Count at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- Change From Baseline in the Physician Global Assessment (PGA) at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- PGA Score at Week 36(Week 36)
- PtGA of Arthritis Pain at Week 36(Week 36)
- Change From Week 36 in Duration of Morning Stiffness at Weeks 40, 48, 56, 64, 72, 80, 88(Weeks 36, 40, 48, 56, 64, 72, 80, 88)
- Percentage of Participants Achieving an Acceptable State on the Patient Acceptable Symptom State (PASS) at Baseline and Week 36(Baseline, Week 36)
- Percentage of Participants Achieving EULAR Good or Moderate Response at Week 36, 40, 48, 56, 64, 72, 80 and 88(Week 36, 40, 48, 56, 64, 72, 80 and 88)
- Change From Baseline in General Health at Weeks 4, 8, 12, 20, 28 and 36(Baseline, Weeks 4, 8, 12, 20, 28 and 36)
- General Health at Week 36(Week 36)
- Change From Week 36 in General Health at Weeks 40, 48, 56, 64, 72, 80, 88(Weeks 36, 40, 48, 56, 64, 72, 80, 88)
- Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good or Moderate Response at Weeks 4, 8, 12, 20, 28 and 36(Weeks 4, 8, 12, 20, 28 and 36)
- Percentage of Participants With an ACR20 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Percentage of Participants With an ACR70 Response at Weeks 4, 8, 12, 20, 28 and 36(Weeks 4, 8, 12, 20, 28 and 36)
- Percentage of Participants With an ACR70 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Percentage of Participants With an ACR90 Response at Weeks 36, 40, 48, 56, 64, 72, 80 and 88(Weeks 36, 40, 48, 56, 64, 72, 80 and 88)
- Percentage of Participants With an ACR90 Response at Weeks 4, 8, 12, 20, 28 and 36(Weeks 4, 8, 12, 20, 28 and 36)
- DAS28 at Week 36(Week 36)
研究者
研究点 (1)
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