NCT01578850已完成4 期
A Randomized, Double-blind Placebo-controlled Study Of The Maintenance Of Efficacy Of Etanercept Plus Dmard(s) Compared With Dmard(s) Alone In Subjects With Rheumatoid Arthritis After Achieving An Adequate Response With Etanercept Plus Dmard(s)
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
- 491
- 试验地点
- 62
- 主要终点
- Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.
研究概览
简要总结
To compare the maintenance of efficacy of the combination of etanercept 50 mg once weekly plus methotrexate with or without other disease modifying antirheumatic drugs therapy with that of methotrexate with or without other disease modifying antirheumatic drugs therapy at Week 52 in subjects with moderately to severely active rheumatoid arthritis who have achieved low disease activity after 24 weeks of therapy with open label etanercept 50 mg once weekly plus MTX with or without other disease modifying antirheumatic drugs therapy.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the 1987 American College of Rheumatology (ACR) Revised criteria for RA.
- •Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of ≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks immediately prior to screening.
排除标准
- •Subjects who used any of the following systemic treatments during the washout periods given below:
- •Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in dose within 28 days of baseline.
- •Treatment with more than 1 NSAID within 14 days at baseline.
- •Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate within 28 days of baseline.
- •Subjects will be allowed to continue the following non biologic DMARDs: sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs (including but not limited to gold, penicillamine, azathioprine, cyclophospamide), and biologic DMARDs must have been discontinued at least 2 months prior to Week
- •Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week
- •Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
- •Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
研究组 & 干预措施
Group A
Experimental
干预措施: Etanercept (Drug)
Group B
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Percentage of Participants Who Remained in Low Disease Activity (LDA) (Disease Activity Score in 28 Joints-erythrocyte Sedimentation Rate [DAS28-ESR] <3.2) at Week 52.
时间窗: Baseline and Week 52
Proportion of participants who remained in LDA DAS28-ESR \<3.2 at Week 52 is presented below.
次要结局
- Percentage of Participants Who Remained in Remission at Week 52 (DAS28-ESR)(Baseline and Week 52)
- Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-C-reactive Protein [CRP]) at Each Visit During Period 1(Baseline, Weeks 4, 8, 16 and 24)
- Percentage of Participants Achieving LDA (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 1(Baseline, Weeks 4, 8, 16 and 24)
- Percentage of Participants Achieving Remission (DAS28-ESR and DAS28-CRP) at Each Visit During Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Percentage of Participants Achieving European League Against Rheumatism (EULAR) Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 1.(Baseline, Weeks 4, 8, 16 and 24)
- Change in the Subject Global Assessment of Arthritis in Period 1(Baseline, Weeks 4, 8, 16 and 24)
- Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 1(Baseline, Weeks 4, 8, 16 and 24)
- Change in Morning Stiffness (Measured in Minutes) at Each Visit During Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change From Baseline in DAS28-CRP and DAS28-ESR in Period 1(Baseline, Weeks 4, 8, 16 and 24)
- Change From Baseline in DAS28-CRP and DAS28-ESR in Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change of CDAI and SDAI at Each Visit During Period 1.(Baseline, Weeks 4, 8, 16 and 24)
- Percentage of Participants Achieving American College of Rheumatology (ACR) ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 1 at Each Visit.(Baseline, Weeks 4, 8, 16 and 24)
- Percentage of Participants Achieving ACR20, ACR50, ACR70 and ACR90 (by 66/68 Joint Counts) During Period 2 at Each Visit.(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change in the Tender and Swollen Joint Counts at Each Visit During Period 2 (Using 28 Joint Count as Well as 66/68 Joint Counts).(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change in the Subject General Health VAS and Pain VAS at Each Visit During Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Percentage of Participants Who Had a Recurrence of Disease Symptoms During Period 2, Based on the Protocol Criteria(Baseline and Week 52)
- Percentage of Participants Achieving EULAR Good and or Moderate Responses (by Both DAS28-ESR and DAS28-CRP Scores) at Each Visit During Period 2.(Baseline, Weeks 24, 28, 36, 44 and 52)
- Percentage of Participants Achieving LDA or Remission Based on Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) at Each Visit During Period 1.(Baseline, Weeks 4, 8, 16 and 24)
- Percentage of Participants Achieving LDA or Remission Based on CDAI and SDAI at Each Visit During Period 2.(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change of CDAI and SDAI at Each Visit During Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change in the Tender and Swollen Joint Counts at Each Visit During Period 1 (Using 28 Joint Count as Well as 66/68 Joint Counts).(Baseline, Weeks 4, 8, 16 and 24)
- Change in the Physician Global Assessment of Arthritis at Each Visit During Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change in the Physician Global Assessment of Arthritis at Each Visit During Period 1(Baseline, Weeks 4, 8, 16 and 24)
- Change in the Subject General Health Visual Analog Scale (VAS) and Pain VAS at Each Visit During Period 1(Baseline, Weeks 4, 8, 16 and 24)
- Change in the Subject Global Assessment of Arthritis in Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change in CRP and ESR at Each Visit During Period 2(Baseline, Weeks 24, 28, 36, 44 and 52)
- Change in CRP and ESR at Each Visit During Period 1(Baseline, Weeks 4, 8, 16 and 24)
研究者
研究点 (62)
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