The Relation Between Dedicated Extremity MRI Synovitis and Structural Deterioration Radiographic in Patients With Rheumatoid Arthritis in Clinical Remission.Preliminary Study
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)
研究概览
简要总结
The major aim of treatment for rheumatoid arthritis is remission. Nevertheless, structural radiographic progression is observed in 15 to 20% of patient getting remission. Numerous definitions of the remission proposed by literature remain imperfect.
Recently ultrasonography and MRI seem to be helpful in diagnosis and follow-up of rheumatoid arthritis.
Studies in patients with clinical remission are reporting 75 to 90% of persistent MRI and ultrasonography synovitis, 45% of cases with synovial activity.
To our knowledge, in such case few studies showed correlation between persistent imaging synovitis and structural radiographic progression.
On the other hand, no studies with extremity dedicated RMI in patients with remission are reported.
In this preliminary study, the investigators propose to evaluate in patients with rheumatoid arthritis remission and persistent dedicated MRI synovitis the structural radiographic progression at one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Earlier rheumatoid arthritis (<1 year)
- •Clinical remission (DAS 28 <2,6 ou SDAI <5) since 6 months before the inclusion
- •Unchanged DMARds and /or biologic therapy since 6 months before the inclusion
- •Unchanged corticosteroid (5 mg/day) since 3 months before the inclusion in patients treated with this therapy
- •No contre-indication to the MRI
排除标准
- •Contra-indication to MRI
- •Pregnant or breast-feeding women
结局指标
主要结局
Dedicated extremity MRI (hand and wrist)/ X-Ray (hand, wrist and foot)
时间窗: at Month 0 (first visit) and Month 12 (last visit)
次要结局
- Ultrasonography (hand, wrist and foot)(at Month 0 (first vist) and Month 12 (last visit))