Doxycycline Outcomes in Lupus Erythematosus: (DOLE)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.
研究概览
简要总结
Cardiovascular disease, specifically from atherosclerosis, is the major cause of mortality in SLE in developed countries. In a recent study the investigators have shown that high sensitivity C reactive protein (hs-CRP) is higher in SLE patients with (versus without) coronary calcium, a measure of subclinical atherosclerosis. In an ongoing two year intervention trial of atorvastatin, the investigators will determine if statins retard coronary calcium and reduce hs-CRP. However, 10% of the patients in the trial were intolerant of statins. The investigators want to now investigate whether there are additional, and potentially safer ways, to reduce hs-CRP in SLE. In this study, the investigators will determine if doxycycline reduces hs-CRP and other vascular inflammatory markers including interleukin 6 (IL-6), soluble vascular cell adhesion molecule (sVCAM-1), soluble inter cell adhesion molecule (s-ICAM-1) and matrix metalloproteinase 9 (MMP-9) in SLE.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •Patients with a clinical diagnosis of SLE, with a hs-CRP above > 3mg/L, (high risk level) for the last 3 months, are eligible.
- •Patients must be 18 years of age or older and able to give informed consent.
- •Contraception other than OCPs is necessary if a woman is at risk for pregnancy.
排除标准
- •SLE patients who are allergic to doxycycline or other tetracyclines.
- •Patients who are pregnant or are planning to become pregnant.
- •Patients who are on oral contraceptives (any method of contraception other than OCPs can be used.
- •Tetracycline use within the previous 2 weeks of enrollment.
- •Patients who are currently on statins will be excluded, because statins might reduce hs- CRP.
- •Patients who are on warfarin.
- •Patients whose most recent EKG shows significant cardiac dysrhythmias or heart block.
研究组 & 干预措施
Placebo
placebo
干预措施: Placebo (Drug)
Doxycycline
Doxycycline
干预措施: Doxycycline (Drug)
结局指标
主要结局
Determine whether doxycycline 20 mg bid (periostat) versus 100mg bid versus placebo is more effective in reducing hs-CRP.
时间窗: 3 months
次要结局
未报告次要终点