Effect of Treat-to-target Strategies Aiming at Remission Compared With Minimal Disease Activity on Arterial Stiffness in Early Rheumatoid Arthritis - a Randomised Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- The change in PWV over 1-year of treatment
研究概览
简要总结
To investigate the effect of two tight-control treatment strategies, aiming at 1) 2011 American College of Rheumatology/European League Against Rheumatism (ACR/EULAR) definition of remission compare with 2) minimal disease activity (Disease Activity Index in 28 joints [DAS28] <2.6), on arterial stiffness in early rheumatoid arthritis (RA) patients.
To compare the effect of two treatments on arterial stiffness in Early Rheumatoid Arthritis
详细描述
One hundred RA patients with active disease (DAS28 >/=3.2), duration of symptoms less than 2 years, and are disease modifying anti-rheumatic drug naive will participate in this 5-year prospective, hospital-based, open-label, randomized, controlled trial.
All participants will receive 1-year tight-control treatment. One hundred patients will be randomly assigned to two arms. Treatment will be adjusted according to a standardized protocol every 3-monthly aiming at remission defined by the 2011 ACR/EULAR definition (Group 1, n=50, simplified disease activity score [SDAI] ≤3.3) or minimal disease activity (Group 2, n=50, DAS28<2.6). A follow up visit will be conducted at the 5th year to evulate long term effect on vascular outcomes between the two groups.
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
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •fulfilled the 2010 ACR/EULAR classification criteria for RA
- •have symptoms onset of less than 2 years
- •have active disease (DAS28> 3.2)
- •are positive for rheumatoid factor or anti-cyclic citrullinated protein antibodies
排除标准
- •have a history of overt cardiovascular diseases
- •are on aspirin, or HMG-CoA reductase inhibitors (statins) or angiotensin-converting-enzyme inhibitor (ACEI)
- •have severe renal impairment defined as a glomerular filtration rate of less than 30 ml/min/1.73m2
- •have been previously treated with tumor necrosis factor alpha (TNFa) inhibitors or other biological DMARDs
- •on glucocorticoids at a dose >10mg/day
结局指标
主要结局
The change in PWV over 1-year of treatment
时间窗: Baseline and 12 months
The change in PWV over 1-year of treatment
次要结局
- The proportion of patients achieve clinical remission(12 months)
- ACR 20, 50, 70 responses(12 months)
- The proportion of patients with a good response(12 months)
- The change in Alx@75 over 1-year of treatment(Baseline and 12 months)
- The change in AIx@75 and PWV over 5-year of treatment(Baseline and 5-year)
研究者
Lai-Shan Tam
Professor
Chinese University of Hong Kong