Value of Ultrasound for Evaluating Rheumatoid Arthritis in Remission: Longitudinal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- 1 year pejorative evolution
研究概览
简要总结
The objective of this study is to determine the longitudinal relation between clinical remission and ultrasound (US) remission in Rheumatoid arthritis (RA).
At a patient level, US-detected residual synovitis (evaluated both by US grey-scale signals and power Doppler signals) is frequent in patients with RA in clinical remission. Several longitudinal studies reveal an association of US-detected residual synovitis and risk of relapse and radiographic progression, in individual patients and joints, over 1-2 years.
However, the longitudinal relation between clinical remission and US remission is not so well-known and it is possible that clinical remission arrive before ultrasound remission. Thus arise the question as to whether the presence of US-detected residual synovitis require to adapt the treatment to ultrasound findings or to simply increase the patient care.
The investigator propose to conduct a prospective, bi-center, non randomized study.
详细描述
The study population will include all RA patient at least 18 years old in clinical remission for less than 6 month.
The primary endpoint (ability of US-detected residual synovitis to predict relapse or radiographic progression in individual patients and joints) will be evaluated afer 12 months of follow-up The total follow-up will be 12 months with a follow-up every 3 months. In addition to the standard care, each follow-up will include an ultrasound examination of 40 joints and 8 tendons
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Age ≥ 18 years
- •PR fulfilling ARC / EULAR (European League Against Rheumatism) 2010 criteria
- •Patient treated by DMARDs (disease-modifying antirheumatic drug)
- •Patient in confirmed remission for less than 6 months
排除标准
- •Patient participating simultaneously in another clinical study with blind treatment
- •Patient participating simultaneously in another clinical study involving decreasing of drug dose
- •Patient in post clinical study exclusion period
- •patients subject to legal protection measures
- •Patient unable to read French
- •Pregnant or breast-feeding women
- •patient treated with Rituximab
研究组 & 干预措施
Study patient
Articular ultrasound at each study follow-up
干预措施: Articular ultrasound (Other)
结局指标
主要结局
1 year pejorative evolution
时间窗: 1 year after inclusion
Number of patient with a clinical relapse
次要结局
- Structural progression(1 year after inclusion)
- RA (Rheumatoid Arthritis) remission duration(At each follow-up (3,6,9 and 12 months after inclusion))
- RA ultrasound remission duration(At each follow-up (3,6,9 and 12 months after inclusion))
- RA clinical remission duration(At each follow-up (3,6,9 and 12 months after inclusion))
- Clinical relapse at one year(1 year after inclusion)
- Persistence of ultrasound synovitis (lenght of RA evolution, lenght of clinical remission, anti-CCP, biological inflammatory symptom persistence, treatments)(At baseline)
- Radiographic progression at 1 year(1 year after inclusion)
- Intra-observator reproductibility(1 year after inclusion)