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

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ClinicalTrials.gov Identifier: NCT01954381
Recruitment Status : Completed
First Posted : October 1, 2013
Last Update Posted : July 22, 2015
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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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.


Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Device: transthoracic echocardiographic Device: Doppler ultrasound. Biological: blood samples Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
Study Start Date : October 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : July 2015

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Arms and Interventions
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Arm Intervention/treatment
control Device: transthoracic echocardiographic
Device: Doppler ultrasound.
Biological: blood samples
Experimental: patient Device: transthoracic echocardiographic
Device: Doppler ultrasound.
Biological: blood samples


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01954381


Locations
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France
Assistance Publique Hopitaux de Marseille
Marseille, France
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01954381    
Other Study ID Numbers: 2011-002883-26
2011-15 ( Other Identifier: AP HM )
First Posted: October 1, 2013    Key Record Dates
Last Update Posted: July 22, 2015
Last Verified: September 2014
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases