REVECHO Study (REmission Véritable en ECHOgraphie) Is Ultrasound Remission a Real Remission? Does Ultrasound Permit to Achieve and Maintain the Remission in Rheumatoid Arthritis Patients More Efficiently Than Clinical Scores?
试验速览
- 阶段
- 不适用
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Time to loss of remission, as clinically defined by a DAS28 score ≥2.6
研究概览
简要总结
Remission is nowadays an achievable objective for Rheumatoid Arthritis (RA) patients thanks to a large choice of therapies, early treatment and tight control (30% relapse).
Ultrasound (US) driven-therapy, complemented with a clinico-biological follow-up, may improve the prognosis of RA in remission by increasing the duration of sustained remission and by preventing radiographic structural progression.
The tested hypothesis is: The US coverage of RA allows to increase the duration of sustained clinical remission.
详细描述
REVECHO is an international prospective multicentre simple blinded randomized study with a longitudinal follow-up of 18 months and a total study duration of 48 months. During the first visit, after having signed the consent form, Patients undergo at each visit, a clinical evaluation comprising an assessment of tender joint count (TJC), of swollen joint count (SJC), pain assessment, patient global assessment of the activity of disease, as well as a physician global assessment of the disease activity, an ultrasound examination of small and large joints by an independent physician blinded to the clinical data, and to the results of biological exams (blood sampling to assess CRP, complete blood count (CBS), and renal and hepatic functions). The clinical, biological and ultrasound assessments will be performed every 3 months.
Patients will be then randomly assigned to one of the 3 groups: 1) "Usual care group", 2) "Clinical (DAS28)-ultrasound follow-up group" (ultrasound-driven therapy) or 3) "DAS28-ACR/EULAR remission criteria group" (ACR/EULAR remission criteria-driven therapy), with a follow-up of 18 months.
Therapeutic decisions are taken by the Referring Rheumatologist. He/she will have DAS28 + US results in the group US follow-up or DAS28 + ACR/EULAR remission criteria results in the group ACR/EULAR follow-up. Therapeutic recommendations (therapeutic options, according to the randomization group, a threshold of activity will be decided by a scientific committee for increasing, stop or change therapy) will be given according to the group of randomization and based on the level of inflammation. The Referring Rheumatologist, will be free to follow or not the therapeutic advices.
In "Usual care" group, DAS28 and PDUS assessment will be performed at each time point, however, no suggestion neither DAS28 nor PDUS results will be given to the Referring Rheumatologist. The Referring Rheumatologist will be free to manage the patient as he/she thinks more appropriate.
Conventional radiography (hand and feet) will be performed at baseline and at M18 follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
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
- •RA patients (ACR 2010 criteria)
- •Disease duration ≤12 years
- •Patients of both genders above 18 years old
- •Remission according to DAS28 criteria (DAS28<2.6) since at least 3 months
- •Treated with DMARDS and/or biologics with stable posology since at least 3 months
- •Treated with corticosteroids ≤5 mg/day (oral, local intra-articular or perfusion) since at least 3 months
- •Affiliated to a regimen of health insurance (only for French sites)
- •Having signed a consent form
- •The patient is considered reliable, willing and capable of adhering to the protocol (for example, able to understand and complete diaries), visit schedule, and medication intake according to the judgment of the Investigator
排除标准
- •Pregnant women
- •Predictable difficulties of follow-up
研究组 & 干预措施
Usual care
Usual care and follow-up every 3 months
干预措施: Usual care (Other)
US-driven therapy
Clinical evaluation according to DAS28 + US every 3 months
干预措施: US power doppler (Device)
ACR/EULAR remission criteria-driven therapy
Clinical evaluation according to DAS28 + ACR/EULAR remission criteria every 3 months
干预措施: ACR/EULAR criteria (Other)
结局指标
主要结局
Time to loss of remission, as clinically defined by a DAS28 score ≥2.6
时间窗: Up to 18 months
The DAS28 (Disease Activity Score for Rheumatoid Arthritis) score is calculated on the basis of swollen joint count (SJC) and tender joint count (TJC) out of 28 (shoulder, elbow, wrist, metacarpophalangeal (MCP) I-V, proximal interphalangeal (PIP) I-V, and knee) as follows: DAS28-CRP= 0.56 x √TJC + 0.28 x √SJC + 0.36 x Ln (CRP + 1) + 0.014 x GA + 0.96 As a result, the DAS28 index gives a value between 0 and 10, with: * \>5.1 indicating high disease activity * 3.2-5.1 indicating moderate disease activity * \<3.2 indicating low disease activity * \<2.6 complete remission
次要结局
- Percentage of RA patients in clinical remission (DAS28 <2.6) at 18 months(18 months)
- Percentage of RA patients without radiographic structural progression(18 months)
- Evolution of the RAPID score and HAQ(18 months)