Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01954381|
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : July 22, 2015
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:
- in vivo study of endothelial function by measuring the post-ischaemic dilatation by 2D ultrasound;
- study of large artery stiffness by pulse wave velocity determined by aplannation tonometry;
- study of central pulse pressure;
- evaluation of atherosclerosis-related parameters such as intima-media thickness.
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.
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Device: transthoracic echocardiographic Device: Doppler ultrasound. Biological: blood samples||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||July 2015|
|control||Device: transthoracic echocardiographic Device: Doppler ultrasound. Biological: blood samples|
|Experimental: patient||Device: transthoracic echocardiographic Device: Doppler ultrasound. Biological: blood samples|
- evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on [ Time Frame: 3 YEARS ]- aortic stiffness by measuring carotid-femoral pulse wave velocity (CF-PWV)
- evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on [ Time Frame: 3 YEARS ]- central pulse pressure (aortic)
- evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on [ Time Frame: 3 YEARS ]- endothelial function by studying hyperaemia-induced vasodilation (FMD), reflecting the quality of endothelium-dependent vasorelaxation
- evaluate the resting blood pressure [ Time Frame: 3 YEARS ]
- evaluate the systolic pressure index [ Time Frame: 3 YEARS ]
- evaluate the structure of the carotid wall [ Time Frame: 3 YEARS ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954381
|Assistance Publique Hopitaux de Marseille|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|