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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01954381
First received: October 13, 2011
Last updated: September 1, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
Device: transthoracic echocardiographic
Device: Doppler ultrasound.
Biological: blood samples
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    - 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 ] [ Designated as safety issue: No ]
    - central pulse pressure (aortic)

  • evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
    - endothelial function by studying hyperaemia-induced vasodilation (FMD), reflecting the quality of endothelium-dependent vasorelaxation


Secondary Outcome Measures:
  • evaluate the resting blood pressure [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
  • evaluate the systolic pressure index [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]
  • evaluate the structure of the carotid wall [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: October 2011
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
control Device: transthoracic echocardiographic Device: Doppler ultrasound. Biological: blood samples
Experimental: patient Device: transthoracic echocardiographic Device: Doppler ultrasound. Biological: blood samples

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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 .
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01954381

Contacts
Contact: pascal rossi pascal.rossi@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France
Contact: pascal rossi       pascal.maurice@ap-hm.fr   
Contact: nathalie lesavre       nathalie.lesavre@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01954381     History of Changes
Other Study ID Numbers: 2011-002883-26, 2011-15
Study First Received: October 13, 2011
Last Updated: September 1, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on September 18, 2014