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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

October 13, 2011
September 1, 2014
October 2011
October 2014   (final data collection date for primary outcome measure)
  • 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
Same as current
Complete list of historical versions of study NCT01954381 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
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.

Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Rheumatoid Arthritis
  • Device: transthoracic echocardiographic
  • Device: Doppler ultrasound.
  • Biological: blood samples
  • control
    Interventions:
    • Device: transthoracic echocardiographic
    • Device: Doppler ultrasound.
    • Biological: blood samples
  • Experimental: patient
    Interventions:
    • Device: transthoracic echocardiographic
    • Device: Doppler ultrasound.
    • Biological: blood samples
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
April 2015
October 2014   (final data collection date for primary outcome measure)

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 .
Both
18 Years and older
Yes
Contact: pascal rossi pascal.rossi@ap-hm.fr
France
 
NCT01954381
2011-002883-26, 2011-15
No
Assistance Publique Hopitaux De Marseille
Assistance Publique Hopitaux De Marseille
Not Provided
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
Assistance Publique Hopitaux De Marseille
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP