A Randomized, Double-blind, Placebo-controlled Study Of The Safety And Efficacy Of Etanercept In Subjects With Rheumatoid Arthritis Who Have Had An Inadequate Response To Adalimumab Or Infliximab Plus Methotrexate
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 16
- 试验地点
- 14
- 主要终点
- Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.
研究概览
简要总结
The first 12 weeks of this study will compare the efficacy of etanercept 50 mg once-weekly to placebo in subjects with rheumatoid arthritis who have not responded well to infliximab or adalimumab plus methotrexate. This comparison will be performed for all subjects and separately for subjects who are anti-drug antibody positive for one of these medications. From week 12 to week 24, all subjects will receive etanercept 50 mg once-weekly. The effect of anti-drug antibody status on the efficacy of etanercept as well as the safety profile of etanercept in these subjects will also be evaluated throughout the study.
详细描述
This study was prematurely terminated on June 25, 2014 due to significant and continuing delays in achieving the study B1801355 enrolment target. The decision to stop the study was not driven by any safety concerns.
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 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Met the 1987 ACR Revised Criteria for RA
- •A history of inadequate response to infliximab or adalimumab in combination with methotrexate.
- •A stable dose of oral methotrexate for at least 6 weeks before the baseline visit.
排除标准
- •ACR functional class IV
- •Prior treatment with etanercept; both infliximab and adalimumab; or any immunosuppressive biologic agent other than infliximab or adalimumab.
- •Discontinuation of infliximab or adalimumab for a primary reason other than inadequate efficacy response.
研究组 & 干预措施
Group A
Subjects who are mAb ADA positive
干预措施: Etanercept (Drug)
Group B
Subjects who are mAb ADA negative
干预措施: Etanercept (Drug)
Group C
Subjects who are mAb ADA positive
干预措施: Placebo (Drug)
Group D
Subjects who are mAb ADA negative
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in the Disease Activity Score Based on a 28 Joint Count (DAS28-C-reactive Protein [CRP]) at Week 12.
时间窗: Baseline, 12 weeks
DAS28 calculated from the number of swollen joints (SJC) and painful joints (PJC) using the 28 joints count, the c-reactive protein (CRP) and Subject General Health Visual Analogue Scale (VAS) assessment (participant rated health assessment with scores ranging 0 to 100; higher scores indicate worse health status).
次要结局
- Change From Baseline in Patient Acceptable Symptom State (PASS)(Baseline, 12 weeks, 24 weeks)
- Number of Participants With Positive Etanercept Neutralizing Anti-drug Antibody Status(Baseline, 12 weeks, 24 weeks)
- Number of Participants Achieving European League Against Rheumatism (EULAR) Good and/or Moderate Response.(12 weeks, 24 weeks)
- Number of Participants Achieving Low Disease Activity or Remission Based on Clinical Disease Activity Index (CDAI)(12 weeks, 24 weeks)
- Change From Baseline in Number of Tender/Painful Joints(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Physician Global Assessment of Disease Activity(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Health Assessment Questionnaire Disability and Discomfort Scales (HAQ-DI)(Baseline, 12 weeks, 24 weeks)
- Number of Participants With DAS28 <3.2(12 weeks, 24 weeks)
- Change From Baseline in Short Form-36 Health Survey (SF-36)(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Vectra Disease Activity Levels(Baseline, 12 weeks, 24 weeks)
- Number of Participants With Positive Etanercept Anti-drug Antibody Status(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Euro Quality of Life (Qol) EQ-5 Dimensions Questionnaire (EQ-5D)(Baseline, 12 weeks, 24 weeks)
- Number of Participants Achieving American College of Rheumatology 20% (ACR20) Response(12 weeks, 24 weeks)
- Number of Participants Achieving American College of Rheumatology 50% (ACR50) Response(12 weeks, 24 weeks)
- Number of Participants Achieving American College of Rheumatology 70% (ACR70) Response(12 weeks, 24 weeks)
- Number of Participants Achieving American College of Rheumatology 90% (ACR90) Response(12 weeks, 24 weeks)
- Number of Participants Achieving Low Disease Activity or Remission Based on Simplified Disease Activity Index (SDAI).(12 weeks, 24 weeks)
- Change From Baseline in CDAI(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Subject Pain(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in CRP(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in the DAS28 at Week 24(Baseline, 24 weeks)
- Number of Participants With DAS28 <2.6(12 weeks, 24 weeks)
- Change From Baseline in SDAI.(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Number of Swollen Joints(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Subject Global Assessment of Disease Activity(Baseline, 12 weeks, 24 weeks)
- Change From Baseline in Subject General Health VAS.(Baseline, 12 weeks, 24 weeks)