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

NCT01954381 | Completed Phase 3

• 2 other identifiers: 2011-002883-262011-15
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (3)

• evaluate the resting blood pressure

  3 YEARS

• evaluate the systolic pressure index

  3 YEARS

• evaluate the structure of the carotid wall

  3 YEARS

Study Arms (2)

control

OTHER

Device: transthoracic echocardiographic; Device: Doppler ultrasound.; Biological: blood samples

patient

EXPERIMENTAL

Device: transthoracic echocardiographic; Device: Doppler ultrasound.; Biological: blood samples

Interventions

transthoracic echocardiographic DEVICE

control; patient

Doppler ultrasound. DEVICE

control; patient

blood samples BIOLOGICAL

control; patient

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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 .

Sponsors & Collaborators

• Assistance Publique Hopitaux De Marseille: lead

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, France

Location

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Ultrasonography, Doppler; Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Clinical Laboratory Techniques; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• BERNARD BELAIGUES

  Assistance Publique hôpitaux de Marseille

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2011
• First Posted: October 1, 2013
• Study Start: October 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: July 1, 2015
• Last Updated: July 22, 2015

Record last verified: 2014-09

Locations

FR (1)