NCT03085940已完成不适用
Role of Hydroxychloroquine to Improve Endothelial Dysfunction in Patients With Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Endothelial dysfunction marker
研究概览
简要总结
Rheumatoid arthritis (RA) increase cardiovascular risk and endothelial dysfunction. Hydroxychloroquine (HCQ) is expected to improve endothelial dysfunction through some metabolic effects. The investigators intend to find the role of HCQ to improve endothelial dysfunction in RA patients. This study will also evaluate correlation HOMA-IR (homeostasis model assessment-estimated insulin resistance), FFA (free fatty acid) and ox-LDL (oxidized-LDL) level change, with endothelial dysfunction improvement.
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 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Rheumatoid Arthritis patients (2010 ACR/EULAR criteria)
- •Being or will be treated with methotrexate (monotherapy)
- •Agree to join the study
排除标准
- •Autoimmune diseases other than RA
- •Acute severe infection, acute coronary syndrome, heart failure, stroke
- •Malignancy or chronic inflammatory diseases
- •Eye disease involving the retina and visual field defects
- •G6PD (glucose 6-phosphate dehydrogenase) deficiency
- •History of smoking within last 5 years
- •Lipid lowering, insulin resistance lowering, antidiabetic, insulin, ACE(angiotensin converting enzyme)-inhibitor or ARB(angiotensin receptor blocker) drugs
研究组 & 干预措施
Hydroxychloroquine
Experimental
干预措施: Hydroxychloroquine (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Endothelial dysfunction marker
时间窗: 3 months
E-Selektine
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Hydroxychloroquine in Cardiovascular Disease in Patients With Chronic Kidney Disease: A Proof of Concept StudyCardiovascular DiseaseArteriosclerosisKidney Failure, ChronicNCT01537315University of Arkansas8
已完成
2 期
Hydroxychloroquine for Japanese patients with rheumatoid arthritisD001172Rheumatoid arthritisJPRN-jRCTs031180050Kaneko Yuko60
终止
2 期
Study of the Efficiency of Hydroxychloroquine on the Endothelial Dysfunction and Its Vascular Consequences During the Antiphospholipid SyndromeAntiphospholipid Syndrome (APS)NCT02595346University Hospital, Rouen25
已完成
不适用
Monitoring and Preventing Hydroxychloroquine, Plaquenil, Toxicity.Hydroxychloroquine ToxicityNCT03316092Dr. S.S. Michel Clinic1,000
进行中(未招募)
4 期
Hydroxychloroquine in ANCA Vasculitis EvaluationWegener GranulomatosisANCA Associated VasculitisChurg-Strauss SyndromeMicroscopic PolyangiitisNCT04316494Guy's and St Thomas' NHS Foundation Trust43
