NCT01762176已完成不适用
Effect of Early Intensive Treatment in Chinese Patients With Recent-onset Rheumatoid Arthritis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 163
- 试验地点
- 1
- 主要终点
- The proportion of patients who achieve clinical remission
研究概览
简要总结
To compare the effectiveness of two treatment strategies in early rheumatoid arthritis (ERA), namely the delayed usual care and early intensive care, in Hong Kong.
- The delayed usual care reflects the usual treatment practice in Hong Kong
- The early intensive care includes tight monitoring and immediate adjustment of therapy
详细描述
This study is a 1-year non-randomized clinical trial. Two groups of patients (delayed usual care and early intensive care) with diagnosis of rheumatoid arthritis (RA) and with symptoms onset of less than 2 years and disease modifying anti-rheumatic drugs (DMARDs) naive will be recruited. Remission is reached if patients fulfill the Boolean criteria.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •For usual care group:
- •patients with at least 1 tender and swollen joint
- •duration of symptoms less than 2 years
- •no previous use of DMARDs
- •For intensive care group:
- •patients with at least 1 tender and swollen joint
- •duration of symptoms less than 2 years
- •no previous use of DMARDs
- •patients who fulfill the 2010 ACR/EULAR classification criteria for RA
排除标准
- •patients with renal impairment (on dialysis or estimated Glomerular Filtration Rate (eGFR) <30 mL/min/1.73m^2)
结局指标
主要结局
The proportion of patients who achieve clinical remission
时间窗: 12 months
The clinical remission is defined using the latest ACR/EULAR remission criteria (Boolean criteria)
次要结局
- ACR 20, 50, 70 responses(12 months)
- Change in various patient-reported outcomes(12 months)
- Gains in utility(12 months)
- Radiographic progression(12 months)
- MRI outcome(12 months)
研究者
Lai-Shan Tam
Professor
Chinese University of Hong Kong
研究点 (1)
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