Cardiovascular Check-up in Patients With Rheumatoid ArthritisNCT01566851
Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis
An observational study of Cardiovascular Check-up in Patients With Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
Introduction Cardiovascular diseases are the first cause of death in rheumatoid arthritis (RA). In 2010, EULAR Standing Committee for Clinical Affairs provides 10 recommendations for cardiovascular risk management in patients with rheumatoid arthritis, including a cardiovascular risk assessment annually. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Check-up in Patients With Rheumatoid Arthritis
- What is being tested?
- Cardiovascular check-up
- How many people
- 7,000 participants
- Where
- 1 siteFrance
- Study dates
- Jun 2012to Nov 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatoid arthritis
Who may be able to join
- Patients over 18 years, affiliated to RSI, with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy
Who cannot join
- patients under 18 years
- Patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis in France in the Entire Population of the RSI (Other Branches of the Universal Healthcare Insurance Agency)
Introduction Cardiovascular diseases are the first cause of death in rheumatoid arthritis (RA). In 2010, EULAR Standing Committee for Clinical Affairs provides 10 recommendations for cardiovascular risk management in patients with rheumatoid arthritis, including a cardiovascular risk assessment annually.
The goal of this study is to evaluate the application of EULAR recommendations in real life in patients with RA in the french population. Inclusion criteria: all patients over 18 years old with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy, affiliated to the RSI (regime social des independents which correspond to other branches of the universal healthcare insurance agency). Non inclusion criteria: patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone. The following analysis will be performed on the whole database of the RSI, without name identification. Evaluation criteria: at least once a years the prescription of at least one of the following items use in the evaluation of the cardiovascular risk factors: lipides dosage, glycemia, HbA1C, stress test, Carotid ultra-sonography, coronary or lower limbs arteriography, heart ultra-sonography, cardiology clinic, endocrinology clinic. This evaluation will be done on the whole national population of RSI for the year 2011 (01/01/2011 - 31/12/2011). On a subgroup of patients from the region "Provence Alpes Côte d'Azur", the investigators will analyze the year 2009, and compare to year 2011, to evaluate the impact of theses recommendations.
- Being tested
- Cardiovascular check-up
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular check-upOther
Cardiovascular check-up once a year in patients with rheumatoid arthritis
| Study group | Role | What they receive |
|---|---|---|
| Patient | Patients with rheumatoid arthritis Receives: Other: Cardiovascular check-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
the following items use in the evaluation of the cardiovascular risk factors
At least once a years the prescription of at least one of the following items use in the evaluation of the cardiovascular risk factors:
- Lipides dosage
- Glycemia
- HbA1C
- Stress test
- Carotid ultra-sonography
- Coronary or lower limbs arteriography
- Heart ultra-sonography
- Cardiology clinic
- Endocrinology clinic
Measured: at time = 2 years
Secondary outcomes (1)
the following items use in the evaluation of the cardiovascular risk factors on the sub population
The same criteria of primary criteria but on the sub population of Povence Alpes Cote-d'Azur region a comparison of these criteria in 2009 (before EULAR recommendations ) and in 2011 (after EULAR recommendations)
Measured: t=0 and t=2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2012 (estimated)
- Study startJun 2012
- Primary completionNov 2012
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular Check-up in Patients With Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 7,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Liana EULLER-ZIEGLER, PU-PH, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01566851
- Sponsor's protocol ID
- 12-01
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2012
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis in France in the Entire Population of the RSI (Other Branches of the Universal Healthcare Insurance Agency)
- ClinicalTrials.gov ID
- NCT01566851
- Acronym / sponsor ID
- 12-01
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7,000 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Jun 2012 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 29 Mar 2012 (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.
Introduction Cardiovascular diseases are the first cause of death in rheumatoid arthritis (RA). In 2010, EULAR Standing Committee for Clinical Affairs provides 10 recommendations for cardiovascular risk management in patients with rheumatoid arthritis, including a cardiovascular risk assessment annually.
The goal of this study is to evaluate the application of EULAR recommendations in real life in patients with RA in the french population. Inclusion criteria: all patients over 18 years old with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy, affiliated to the RSI (regime social des independents which correspond to other branches of the universal healthcare insurance agency). Non inclusion criteria: patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone. The following analysis will be performed on the whole database of the RSI, without name identification. Evaluation criteria: at least once a years the prescription of at least one of the following items use in the evaluation of the cardiovascular risk factors: lipides dosage, glycemia, HbA1C, stress test, Carotid ultra-sonography, coronary or lower limbs arteriography, heart ultra-sonography, cardiology clinic, endocrinology clinic. This evaluation will be done on the whole national population of RSI for the year 2011 (01/01/2011 - 31/12/2011). On a subgroup of patients from the region "Provence Alpes Côte d'Azur", the investigators will analyze the year 2009, and compare to year 2011, to evaluate the impact of theses recommendations.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient | – | Other: Cardiovascular check-upPatients with rheumatoid arthritis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis
Key inclusion criteria (1 listed)
- Patients over 18 years, affiliated to RSI, with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy
Key exclusion criteria (2 listed)
- patients under 18 years
- Patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone
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 |
|---|---|---|
| Cardiovascular check-upCardiovascular check-up once a year in patients with rheumatoid arthritis | Other | Patient |
Primary outcome
the following items use in the evaluation of the cardiovascular risk factors
Time frame: at time = 2 years
At least once a years the prescription of at least one of the following items use in the evaluation of the cardiovascular risk factors: * Lipides dosage * Glycemia * HbA1C * Stress test * Carotid ultra-sonography * Coronary or lower limbs arteriography * Heart ultra-sonography * Cardiology clinic * Endocrinology clinic
1 secondary outcome
the following items use in the evaluation of the cardiovascular risk factors on the sub population
Time frame: t=0 and t=2 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 16 Jun 2026.
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.
Liana EULLER-ZIEGLER, PU-PH principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Check-up in Patients With Rheumatoid Arthritis, run by Centre Hospitalier Universitaire de Nice 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 1 inclusion and 2 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 16 Jun 2026. 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.
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?
the following items use in the evaluation of the cardiovascular risk factors (time frame: at time = 2 years). 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 16 Jun 2026.