Peroxisome Proliferator-activated Receptor-gamma Agonists, Rheumatoid Arthritis and Cardiovascular Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 143
- 试验地点
- 1
- 主要终点
- Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia
研究概览
简要总结
Patients with rheumatoid arthritis have a significantly higher risk to develop heart attacks and other complications of their blood vessels. New therapies are needed to prevent this complication. The purpose of this study is to establish the role of the medication pioglitazone in improving the function of the blood vessels and heart and decreasing the risk of future atherosclerosis development in individuals with rheumatoid arthritis. As a secondary aim-point, we will evaluate the efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation.
详细描述
This study will establish the role of pioglitazone in improvement of endothelial function, arterial compliance and disease activity in patients with rheumatoid arthritis. This will be a placebo-controlled, double blind, cross-over trial.
Two of the measures which were initially listed as separate outcome measures: (Decrease in inflammation) and Efficacy of pioglitazone in improving rheumatoid arthritis disease activity and markers of inflammation are now shown as a combined score (DAS-28-CRP). The Risks or Side Effects as an outcome measure would be duplicative of the tables in the adverse event section and therefore were deleted as an outcome measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 21 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Women on adequate contraception if they are of child-bearing age.
- •Meet revised ACR criteria for RA.
- •Stable doses of DMARDS,biologic agents and or corticosteroids for at least 3 months.
排除标准
- •Pregnant or lactating women.
- •Current smokers or individuals who smoked in the last 6 months.
- •Diagnosis of Diabetes, heart failure, or infection.
- •Current diagnosis of malignant disease except for basal cell or squamous cell carcinoma of the skin.
- •No active liver disease.
- •No cholesterol-lowering medications or oral hypoglycemic agents.
研究组 & 干预措施
Pioglitazone then placebo
Oral daily pioglitazone 30 mg tablets daily for 2 weeks, followed by 45 mg daily tablets until end of study for 3 months compared to placebo in tablets of equal presentation for 3 months, then crossover after a 2 month washout.
干预措施: pioglitazone (Drug)
Pioglitazone then placebo
Oral daily pioglitazone 30 mg tablets daily for 2 weeks, followed by 45 mg daily tablets until end of study for 3 months compared to placebo in tablets of equal presentation for 3 months, then crossover after a 2 month washout.
干预措施: Sublingual nitroglycerine (Drug)
placebo then study drug (pioglitazone)
Oral daily placebo for 3 months compared to pioglitazone for 3 months, then crossover after a 2 month washout. Similar doses as mentioned above.
干预措施: pioglitazone (Drug)
placebo then study drug (pioglitazone)
Oral daily placebo for 3 months compared to pioglitazone for 3 months, then crossover after a 2 month washout. Similar doses as mentioned above.
干预措施: Sublingual nitroglycerine (Drug)
结局指标
主要结局
Brachial Artery Diameter Change From Baseline in Response to Reactive Hyperemia
时间窗: 8 months
This measure represents the percentage change in diameter of brachial artery in response to reactive hyperemia. The data is presented intentionally and only for the results at the conclusion of the study.
次要结局
- Rheumatoid Arthritis Disease Activity(8 mo)
研究者
Mariana Kaplan
Associate Professor
University of Michigan