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Completed

NCT Number: NCT01954381

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Assistance Publique Hopitaux de Marseille

Marseille, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

transthoracic echocardiographic

Device

Doppler ultrasound.

Device

blood samples

Biological

Primary outcomes

  1. 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)

  2. evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on

    Time frame: 3 YEARS

    • central pulse pressure (aortic)

  3. 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

Secondary outcomes

  1. evaluate the resting blood pressure

    Time frame: 3 YEARS

  2. evaluate the systolic pressure index

    Time frame: 3 YEARS

  3. evaluate the structure of the carotid wall

    Time frame: 3 YEARS

Sponsors and collaborators

Lead sponsor

Assistance Publique Hopitaux De Marseille

Other

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2015
First posted
Oct 1, 2013
Registry last updated
Jul 22, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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