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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005644-33 | EudraCT Number |
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No more inclusion
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Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying antirheumatic drugs (DMARDs).
Among DMARDs available in 2015, researchers demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept treatment initiation.
Rheumatoid Arthritis patients management reposes primarily on the use of disease-modifying anti-rheumatic drugs. In patients responding insufficiently to Methotrexate, and/or other disease-modifying anti-rheumatic drugs (DMARD) strategies, with or without glucocorticoids, biological DMARD (TNF inhibitors, abatacept or tocilizumab, and, under certain circumstances, rituximab) should be commenced with Methotrexate. Among DMARD available in 2015, abatacept has demonstrated the ability to reduce synovitis, biomarkers of inflammation, and bone destruction. Monitoring rheumatoid arthritis patients after starting abatacept by US exams observed a strong reduction of power Doppler ultra-sonography at 3 months in two third of patients.
Given the demonstration of correlation between joint inflammation and structural progression at each joint level as well as the opportunity for bone remodeling with resolution of joint inflammation, researchers expect to observe an improvement in bone micro-architecture parameters specifically in rheumatoid arthritis patients without remaining joint inflammation 3 months following abatacept initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with rheumatoid arthritis. | Rheumatoid arthritis diagnosis according to ACR (American College of Radiology)/EULAR 2010 classification criteria. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patients with rheumatoid arthritis | Other | Doppler effect at 3 months after Abatacept treatment initiation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Value of joint inflammation | The predictive value of persistent joint inflammation on volumetric trabecular bone density is measured by high resolution pQCT (peripheral Quantitative Computed Tomography) after 1 year treatment with Abatacept. | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Rheumatoid arthritis patients diagnosed according to ACR/EULAR 2010 criteria, and Abatacept therapy sub-cutaneous required according EULAR recommendation.
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| Name | Affiliation | Role |
|---|---|---|
| Hubert MAROTTE, PhD | Centre Hospitalier Universitaire de Saint Etienne | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Édouard Herriot | Lyon | 69000 | France | |||
| Ch Regional D'Orleans |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D004301 | Doppler Effect |
| ID | Term |
|---|---|
| D055585 | Physical Phenomena |
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Blood samples will be performed to determine the predictive value of joint inflammation.
| Orléans |
| 45067 |
| France |
| Assistance Publique-Hopitaux de Paris | Paris | France |
| Chu Saint Etienne | Saint-Etienne | 42100 | France |
| CHU de Toulouse | Toulouse | 31059 | France |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |