Rheumatoid Arthritis Clinical Trial
— BCDOfficial title:
Pragmatic Study Comparing the Clinical Evlauation Methods ( C) and / or Ultrasound Method ( B or D) in Rheumatoid Arthritis (RA) to Adapt Treatment
Verified date | December 2023 |
Source | University Hospital, Brest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 561 |
Est. completion date | November 25, 2022 |
Est. primary completion date | November 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | - Inclusion Criteria: - 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 - Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
France | 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 |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Brest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Assessement of the Xrays evolution at 1 year through adaptated treatment according to clinical or ultrasound remission criteria. | 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). | 1 year | |
Secondary | Evaluation of the proportion of rheumatoid arthristis in remission according to the method used | at 3 month, 6 month, 9 month and 1 year | ||
Secondary | Assessement of the Xrays evolution at 2 years | 2 years |
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