Effect of Hydroxychloroquine on the Annexin A5 Resistance Assay in Antiphospholipid Antibody-Positive Patients With and Without Systemic Lupus Erythematosus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in Annexin A5 resistance assay
研究概览
简要总结
This 12 week study will observe patients with and without systemic lupus erythematosus who have persistent antiphospholipid antibodies in the blood who are starting a medicine called hydroxychloroquine. It will measure if these patients have a change in a blood test called the annexin A5 resistance assay over that 12 week period.
详细描述
Antiphospholipid Syndrome (APS) is an autoimmune disorder of blood clotting and pregnancy loss. It is associated with proteins called antiphospholipid antibodies (aPL) in the blood. Blood clotting in this disease occurs for several reasons; one reason involves the interaction of aPL with another protein found on the surface of the cells that line blood vessels (endothelial cells). This protein, called annexin A5 (AnxA5), forms a shield over the surface of these cells. The AnxA5 Resistance Assay is a blood test that can detect when there is a problem with the protective AnxA5 shield on endothelial cell surfaces.
This 12 week study will observe patients with persistent aPL in the blood who are starting a medicine called hydroxychloroquine (HCQ). The primary goal of the study is to compare results of the AnxA5 resistance assay from patients before they start taking HCQ and after they have taken it for 12 weeks to see if the results of the blood test change. Our secondary goal is to measure a variety of other blood tests before and after patients have started taking HCQ; these tests include D-dimer, Activated Protein C (APC) Resistance, and aPL titers/status (LA test, aCL ELISA, aß2GPI ELISA, and anti-Domain-I ß2GPI ELISA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 to 65
- •new HCQ (200-400 mg/day) treatment (for all but 5 of 10 control subjects - see below)
- •persistently positive aPL
排除标准
- •Steroid use greater than or equal to the equivalent of prednisone 0.5 mg/kg/day at the time of enrollment
- •Heparin use at the time of enrollment
- •Any immunosuppressive drug use within 3 months prior to screening
- •HCQ use within the past 6 months prior to screening visit
- •Another antimalarial agent treatment,
- •Pregnant women, minors, mentally disabled, prisoners
- •Acute thrombosis within 2 weeks prior to screening
结局指标
主要结局
Change in Annexin A5 resistance assay
时间窗: 12 weeks
The primary goal of the study is to compare results of the AnxA5 resistance assay from patients before they start taking HCQ and after they have taken it for 12 weeks to see if the results of the blood test change.
次要结局
- Change in anticardiolipin (aCL) ELISA(Baseline and 12 weeks)
- Change in anti-B2-glycoprotein-I (aB2GPI) ELISA(Baseline and 12 weeks)
- Change in anti-Domain-I B2GPI ELISA(Baseline and 12 weeks)
- Change in activated protein C (APC) resistance coagulation assay(Baseline and 12 weeks)
- Change in LA functional coagulation assay(Baseline and 12 weeks)
- Change in D-dimer(Baseline and 12 weeks)