The Effect of Adalimumab (Humira) on Vascular Abnormalities in Rheumatoid Arthritis. A Pilot Study.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Endothelial expression of HLA-DQ in muscle biopsies
研究概览
简要总结
The purpose of this study is to determine whether anti-inflammatory treatment with adalimumab (Humira) reduces endothelial activation in blood vessels in patients with active rheumatoid arthritis. Markers of endothelial activation are assessed in muscle tissue before treatment and after 3 months, and related to other biomarkers and clinical outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Clinical diagnosis of rheumatoid arthritis
- •Fulfillment of the American College of Rheumatology 1987 criteria for rheumatoid arthritis
- •Active disease despite treatment with at least one disease modifying anti-rheumatic drug
- •Treatment with adalimumab indicated according to the the patient's rheumatologist
- •At least six swollen joints in 28-joint index
- •CRP > 8 mg / L within the last three months
排除标准
- •Treatment with anti-TNF drugs in the last three months
- •Treatment with intravenous corticosteroids within fourteen days
- •Ongoing treatment with oral high-dose corticosteroids (equivalent to ≥ 20 mg of prednisolon daily) or completed such treatment less than fifteen days before inclusion
- •Severe bleeding disorder
- •Extensive or refractory leg ulcers
- •Severe peripheral vascular disease
研究组 & 干预措施
Adalimumab
干预措施: Adalimumab (Drug)
结局指标
主要结局
Endothelial expression of HLA-DQ in muscle biopsies
时间窗: 3 months
Vascular tissue area stained for HLA-DQ by immunohistochemistry, quantified by computer assisted image analysis
Endothelial expression of interleukin-1 alpha in muscle biopsies
时间窗: 3 months
Vascular tissue area stained for interleukin-1 alpha by immunohistochemistry, quantified by computer assisted image analysis
Carotid artery intima-media thickness
时间窗: 3 months
Thickness of the intima and media of the common carotid artery, measured by ultrasound. Mean of two measures of the right and left common carotid artery.
次要结局
未报告次要终点