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

Primary Purpose

Rheumatoid Arthritis

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
transthoracic echocardiographic
Doppler ultrasound.
blood samples
Sponsored by
Assistance Publique Hopitaux De Marseille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Rheumatoid Arthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 .

Sites / Locations

  • Assistance Publique Hopitaux de Marseille

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

control

patient

Arm Description

Outcomes

Primary Outcome Measures

evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
- aortic stiffness by measuring carotid-femoral pulse wave velocity (CF-PWV)
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
- central pulse pressure (aortic)
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

Secondary Outcome Measures

evaluate the resting blood pressure
evaluate the systolic pressure index
evaluate the structure of the carotid wall

Full Information

First Posted
October 13, 2011
Last Updated
July 21, 2015
Sponsor
Assistance Publique Hopitaux De Marseille
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1. Study Identification

Unique Protocol Identification Number
NCT01954381
Brief Title
Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
Official Title
Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
Other
Arm Title
patient
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
transthoracic echocardiographic
Intervention Type
Device
Intervention Name(s)
Doppler ultrasound.
Intervention Type
Biological
Intervention Name(s)
blood samples
Primary Outcome Measure Information:
Title
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
Description
- aortic stiffness by measuring carotid-femoral pulse wave velocity (CF-PWV)
Time Frame
3 YEARS
Title
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
Description
- central pulse pressure (aortic)
Time Frame
3 YEARS
Title
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
Description
- endothelial function by studying hyperaemia-induced vasodilation (FMD), reflecting the quality of endothelium-dependent vasorelaxation
Time Frame
3 YEARS
Secondary Outcome Measure Information:
Title
evaluate the resting blood pressure
Time Frame
3 YEARS
Title
evaluate the systolic pressure index
Time Frame
3 YEARS
Title
evaluate the structure of the carotid wall
Time Frame
3 YEARS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 .
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
BERNARD BELAIGUES
Organizational Affiliation
Assistance Publique hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hopitaux de Marseille
City
Marseille
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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