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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-15 | Other Identifier | AP HM |
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Rheumatoid arthritis (RA) is one of the most common inflammatory diseases in the general population and many cardiovascular diseases (valvular, myocardial, pericardial, coronary disease, stroke, heart failure etc.) have already been described in this disease. Large epidemiological studies have also demonstrated a higher degree of severity of atherosclerotic vascular disease in RA patients, to such a degree that several authors have highlighted the fact that, in the final analysis, the prognosis of RA is rather determined by the severity of atherosclerotic lesions.
By reducing RA-related systemic inflammation, it can therefore be hypothesized that 24 weeks of anti-TNF therapy would improve arterial endothelial function and large artery stiffness.
The proposed study will assess the effects of adalimumab therapy on these parameters. A group of 26 RA patients will be recruited from a rheumatologists association of the French PACA region (CONCERTO association). This study will be non invasive and will comprise:
The results obtained should provide a better understanding of the mechanisms involved in RA-related vascular disease and the effects of anti-TNF therapy.
In view of the high prevalence of RA, this study could potentially interest the medical community as a whole and could be largely diffused.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| control | Other |
| |
| patient | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| transthoracic echocardiographic | Device |
| ||
| Doppler ultrasound. |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on | - aortic stiffness by measuring carotid-femoral pulse wave velocity (CF-PWV) | 3 YEARS |
| evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on | - central pulse pressure (aortic) | 3 YEARS |
| evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on | - endothelial function by studying hyperaemia-induced vasodilation (FMD), reflecting the quality of endothelium-dependent vasorelaxation | 3 YEARS |
| Measure | Description | Time Frame |
|---|---|---|
| evaluate the resting blood pressure | 3 YEARS | |
| evaluate the systolic pressure index | 3 YEARS | |
| evaluate the structure of the carotid wall |
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Inclusion Criteria:
Exclusion Criteria:
Minors, pregnant women, not adequate contraception if female with childbearing potential, majors under guardianship, residents of social welfare or health care establishments, patients presenting an emergency situation, patients not covered by French social security, subjects deprived of their freedom and patients refusing to participate in the clinical research.
Absence of informed consent
Patients who have previously received anti-TNF therapy
Renal failure
History of demyelinising disease
Any unstable medical condition
Patients with recurrent serious infections
History of cardiovascular or cerebrovascular disease
History of cancer
Patients not having TB prophylaxis as per guidelines for latent TB, or patients non-treated active tuberculosis
Contraindication to adalimumab therapy:
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| Name | Affiliation | Role |
|---|---|---|
| BERNARD BELAIGUES | Assistance Publique hôpitaux de Marseille | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hopitaux de Marseille | Marseille | France |
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| Device |
|
| blood samples | Biological |
|
| 3 YEARS |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| 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 |
|---|---|
| D018608 | Ultrasonography, Doppler |
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |
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