Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title: Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

• NCT number: NCT01954381
• Study type: Interventional
• Source: Assistance Publique Hopitaux De Marseille
• Status: Completed
• Phase: Phase 3
• Start date: October 2011
• Completion date: July 2015