Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis to Adapt Treatment
- Conditions
- Rheumatoid Arthritis
- Registration Number
- NCT02410304
- Lead Sponsor
- University Hospital, Brest
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 561
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria. 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).
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (10)
CHU Angers
🇫🇷Angers, France
CHRU Brest
🇫🇷Brest, France
CHU La Roche sur Yon
🇫🇷La Roche sur Yon, France
CH Le Mans
🇫🇷Le Mans, France
CH de Lorient
🇫🇷Lorient, France
CHU Nantes
🇫🇷Nantes, France
CHR Orléans
🇫🇷Orléans, France
CHU SUD Rennes
🇫🇷Rennes, France
CHU Tours
🇫🇷Tours, France
CH Vannes
🇫🇷Vannes, France
CHU Angers🇫🇷Angers, France