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

NCT ID: NCT01954381

Last Updated: 2015-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-10-31
• Study Completion Date: 2015-07-31

Brief 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.

Conditions

Rheumatoid Arthritis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

control

Group Type: OTHER

transthoracic echocardiographic

Intervention Type: DEVICE

Doppler ultrasound.

Intervention Type: DEVICE

blood samples

Intervention Type: BIOLOGICAL

patient

Group Type: EXPERIMENTAL

transthoracic echocardiographic

Intervention Type: DEVICE

Doppler ultrasound.

Intervention Type: DEVICE

blood samples

Intervention Type: BIOLOGICAL

Interventions

transthoracic echocardiographic

Intervention Type: DEVICE

Doppler ultrasound.

Intervention Type: DEVICE

blood samples

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Patients over the age of 18 years
• Patients with RA according to ACR 1987 criteria
• Indication for adalimumab therapy, according to guidelines:
• moderately to severely active RA, when the response to disease-modifying anti-rheumatic drugs, including methotrexate, is inadequate,and,severe, active and active RA in adults not previously treated with methotrexate.

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:

• Hypersensitivity to adalimumab or one of the excipients.
• Active tuberculosis or other severe infections such as sepsis and opportunistic infections
• Moderate to severe heart failure .

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

BERNARD BELAIGUES

Role: STUDY_DIRECTOR

Assistance Publique hôpitaux de Marseille

Locations

Assistance Publique Hopitaux de Marseille

Marseille, , France

Countries

France

Other Identifiers

2011-15

Identifier Type: OTHER

Identifier Source: secondary_id

2011-002883-26

Identifier Type: -

Identifier Source: org_study_id