Rheumatoid ArthritisPhase 3NCT01954381
Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
A Phase 3 study testing transthoracic echocardiographic, Doppler ultrasound. and blood samples in people with Rheumatoid Arthritis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- transthoracic echocardiographic, Doppler ultrasound. and blood samples
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2011to Jul 2015
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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 .
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Rheumatoid Arthritis
- Being tested
- transthoracic echocardiographic, Doppler ultrasound., blood samples
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transthoracic echocardiographicDevice
Doppler ultrasound.Device
blood samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| control | Other | Not described Receives: Device: transthoracic echocardiographic; Device: Doppler ultrasound.; Biological: blood samples |
| patient | Experimental | Not described Receives: Device: transthoracic echocardiographic; Device: Doppler ultrasound.; Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
- aortic stiffness by measuring carotid-femoral pulse wave velocity (CF-PWV)
Measured: 3 YEARS
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
- central pulse pressure (aortic)
Measured: 3 YEARS
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
Measured: 3 YEARS
Secondary outcomes (3)
evaluate the resting blood pressure
Measured: 3 YEARS
evaluate the systolic pressure index
Measured: 3 YEARS
evaluate the structure of the carotid wall
Measured: 3 YEARS
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2013 (estimated)
- Study startOct 2011
- Primary completionOct 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- BERNARD BELAIGUES, Study director, Assistance Publique hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01954381
- Sponsor's protocol ID
- 2011-002883-26
- Other IDs
- 2011-15
- Status last verified
- Sep 2014
- First submitted
- 13 Oct 2011
- Last updated
- 22 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Adalimumab Therapy on Brachial Endothelial Function and Large Artery Stiffness in Patients With Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT01954381
- Acronym / sponsor ID
- 2011-002883-26
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 1 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control | Other | Device: transthoracic echocardiographic, Device: Doppler ultrasound., Biological: blood samples |
| patient | Experimental | Device: transthoracic echocardiographic, Device: Doppler ultrasound., Biological: blood samples |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transthoracic echocardiographic | Device | control, patient |
| Doppler ultrasound. | Device | control, patient |
| blood samples | Biological | control, patient |
Primary outcome
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)
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on
Time frame: 3 YEARS
- central pulse pressure (aortic)
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
3 secondary outcomes
evaluate the resting blood pressure
Time frame: 3 YEARS
evaluate the systolic pressure index
Time frame: 3 YEARS
evaluate the structure of the carotid wall
Time frame: 3 YEARS
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2015.
Related trials for Rheumatoid Arthritis
RecruitingPhase 2
Study of PTC844 in Participants With Active Rheumatoid Arthritis
Rheumatoid Arthritis
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
Not yet recruitingPhase 1
R-2487 in Patients With Sjogren's Syndrome (SjD)
Sjogren's Syndrome, Sjögren
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary Fibrosis, Progressive Pulmonary Fibrosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
BERNARD BELAIGUES study director
Assistance Publique hôpitaux de Marseille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing transthoracic echocardiographic, Doppler ultrasound. and blood samples in people with Rheumatoid Arthritis, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the effects of 24 weeks of anti-TNF (adalimumab) therapy on (time frame: 3 YEARS). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2015.