NCT00910273终止4 期
Effects of Etanercept on Endothelial Function and Carotid Intima-media Thickness (IMT) in Patients With Active AS
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- Pfizer
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12
研究概览
简要总结
Study to assess whether etanercept therapy is able to increase flow-mediated vasodilatation in AS, and whether etanercept can modify the intima-media thickness (IMT) in these patients
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, Care Provider, Investigator)
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
- •Diagnosis of AS, as defined by Modified New York Criteria for Ankylosing Spondylitis.
- •AS with active disease as defined by Bath Ankylosing Spondylitis Disease Activity Index (BASDAI, see Attachment 4) >= 4 at screening visit.
- •Patients capable, in the opinion of the investigator, of complying with the treatment schedule and doses throughout the 52 weeks
- •Agreement by male subjects who are not surgically sterile and female subjects who are not surgically sterile or postmenopausal to use reliable methods of birth control for the duration of the study.
- •Ability to self-inject drug or have a designee who can do so.
- •Ability to store injectable test article at 2ºC to 8ºC.
排除标准
- •Pregnancy confirmed by test taken at screening in all women except those who were surgically sterile or at least 1 year postmenopausal. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception that needs to be continued for 15 days following discontinuation of the test article.
研究组 & 干预措施
1
Experimental
etanercept 50 mg/week
干预措施: etanercept (Drug)
结局指标
主要结局
Change From Baseline in Flow-Mediated Dilatation (FMD) at Week 12
时间窗: Baseline, Week 12
Brachial artery (BA) FMD equals (=)(maximum diameter minus\[-\] baseline diameter divided by baseline diameter) times (\*) 100 percent (%). Ultrasound images of BA at rest were followed by blood pressure (BP) cuff inflated to at least 50 millimeters of mercury (mm Hg) above participants systolic BP for 5 minutes. Cuff released and reactive hyperaemia was produced. BA was imaged continuously from 30 seconds prior cuff inflation to 2 minutes after cuff deflation. Higher scores indicate improved endothelial function.
次要结局
- Change From Baseline in Flow-Mediated Dilatation at Weeks 4, 24, 36, and 52(Baseline, Weeks 4, 24, 36, and 52 or Early Termination (ET))
- Change From Baseline in C-Reactive Protein (CRP) at Weeks 4, 12, 24, 36, 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in Total Serum Homocysteine at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in Carotid Intima Media Thickness (IMT) at Weeks 12 and 52(Baseline, Week 12 and 52 or ET)
- Change From Baseline Lipid Parameters at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Percentage of Participants With Assessment in Ankylosing Spondylitis (ASAS) 20 at Weeks 4, 12, 24, 36, and 52(Week 4, 12, 24, 36, and 52 or ET)
- Percentage of Participants With ASAS 50 at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36 and 52 or ET)
- Percentage of Participants With ASAS 5/6 at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36 and 52 or ET)
- Percentage of Participants With ASAS Partial Remission at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36 and 52 or ET)
- Percentage of Participants With ASAS 40 at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36, and 52 or ET)
- Change From Baseline in Erythrocyte Sedimentation Rate (ESR) at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Week 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36, and 52 or ET)
- Percentage of Participants With BASDAI 50 Percent (%) Improvement at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36, and 52 or ET)
- Percentage of Participants With ASAS 70 at Weeks 4, 12, 24, 36, and 52(Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in BASMI-Intermalleolar Distance at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in BASMI-Tragus to Wall Distance at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in BASMI-Lateral Flexion at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) at Week 4, 12, 24, 36, and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in BASMI-Cervical Rotation at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36, 52 or ET)
- Change From Baseline in BASMI-Modified Schober's Test at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in Occiput-to-Wall Distance at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
- Change From Baseline in Chest Expansion at Weeks 4, 12, 24, 36 and 52(Baseline, Weeks 4, 12, 24, 36 and 52 or ET)
研究者
研究点 (1)
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