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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm C (Clinical) | Other | No drug and no placebo were used in this arm. Patients were followed only by clinical évaluation. |
|
| Arm B (Clinical + Ultrasound) | Other | No drug and no placebo were used in this arm. Patients were followed by Clinical evaluation in combination with ultrasound (in B mode). |
|
| Arm D (Ultrasound) | Other | No drug and no placebo were used in this arm. Patients were followed by Ultrasound approach in D mode. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xrays | Device | Clinical evaluation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU Angers | Angers | 49100 | France | |||
| CHRU Brest |
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| Ultrasound (B mode ) |
| Device |
|
| Ultrasound (D mode) | Device |
|
| Brest |
| 29609 |
| France |
| CHU La Roche sur Yon | La Roche-sur-Yon | 85925 | France |
| CH Le Mans | Le Mans | 72037 | France |
| CH de Lorient | Lorient | 56322 | France |
| CHU Nantes | Nantes | 44093 | France |
| CHR Orléans | Orléans | 45067 | France |
| CHU SUD Rennes | Rennes | 35203 | France |
| CHU Tours | Tours | 37044 | France |
| CH Vannes | Vannes | 56017 | France |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D013585 | Synovitis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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