Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 561
- 试验地点
- 20
- 主要终点
- Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.
研究概览
简要总结
This study compares different methods of clinical evaluation (C) and/or ultrasound (B or D) concerning the rheumatoid arthritis in order to monitore the treatment. This study will provide the exact number of patients in remission according the 3 methods.
It could allow to assess the concordance between the 3 evaluated methods. This study will permit to define the best method which limit the evolution of structural damages ( principal criteria).
详细描述
The aim of this study is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of patients affected by rheumatoid arthritis (ACR/EULAR 2010). The first approach is the assessment of remission defined by modified SDAI in order to evaluate in all cases the same number of joints [Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and and practitioner with VAS, and PCR ≤ 3.3mg/l] (mode C). The second one is a combined approach: clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B). The last one is an ultrasound approach (remission defined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).
This trial is a National randomized multicentre trial that compares three modes of follow to adjust the therapeutic adaptation in Rheumatoid Artritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Both gender patients aged 18 -to 80 years old
- •Patients will be eligible if they fulfill ACR/EULAR 2010 rheumatoid arthritis
- •All the treatment recommended for rheumatoïd arthritis (anti-inflammatory drugs, steroids, hydroxychloroquine, salazopyrine, methotrexate, ARAVA or biologics treatment: Enbrel, humira, remicade, cimzia, tocilizumab, rituximab, abatacept, simponi) would be in stable posology since at least 12 weeks before inclusion
- •Patients would be able to understand and be agree with the protocole
- •Patients would be able to consent
排除标准
- •Patient unable to cooperate patient and who refuse to sign consent form
- •Patient unable to understand the study,under administrative supervision or legal guardianship
- •Signs and symptoms of uncontroled or severe progressive pathology at the level of renal, hepatic, hematological, endocrine, lung, cardiac, neurological or cerebral
- •Scheduled surgery procedure during the study on the estimated joint.
- •Patient non-affiliated to social security
- •Pregnant and nursing mothers
结局指标
主要结局
Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria.
时间窗: 1 year
The primary outcome is to evaluate the Xrays evolution at 1 year ( at least one new erosion versus no erosion with the Sharp modified by van der Heijde) of rheumatoid arthritis patients (ACR/EULAR 2010) according to remission defined by modified SDAI in order to evaluate in all cases the same number of joints \[Simplified Disease Activity Index algebric sum of 5 parametres : number of painful joints (28 joints) , number of synovitis (38 joints), global evaluation of patient and practitioner with VAS, and PCR ≤ 3.3mg/l\] (mode C), with a combined approach clinical-ultrasound (same criteria but with MTPs and shoulders in B mode so a 26 joints evaluation with clinical examination and 12 joints evaluation in B mode) (mode B) or an ultrasound approach (remission défined as the absence of power Doppler on 38 joints (28 of SDAI plus 10 MTPs joints) (mode D) in a pragmatical context (study assessed by private rheumatologists and hospital rheumatologists).
次要结局
- Evaluation of the proportion of rheumatoid arthristis in remission according to the method used(at 3 month, 6 month, 9 month and 1 year)
- Assessement of the Xrays evolution at 2 years(2 years)