We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01566851
Recruitment Status : Unknown
Verified March 2012 by Centre Hospitalier Universitaire de Nice.
Recruitment status was:  Not yet recruiting
First Posted : March 29, 2012
Last Update Posted : March 29, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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.

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.


Condition or disease Intervention/treatment
Cardiovascular Check-up in Patients With Rheumatoid Arthritis Other: Cardiovascular check-up

Study Design

Study Type : Observational
Estimated Enrollment : 7000 participants
Observational Model: Cohort
Time Perspective: Retrospective
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)
Study Start Date : May 2012
Estimated Primary Completion Date : November 2012
Estimated Study Completion Date : November 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Patient
Patients with rheumatoid arthritis
Other: Cardiovascular check-up
Cardiovascular check-up once a year in patients with rheumatoid arthritis


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. the following items use in the evaluation of the cardiovascular risk factors on the sub population [ Time Frame: t=0 and t=2 years ]
    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)


Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients with rheumatoid arthritis
Criteria

Inclusion Criteria:

  • Patients over 18 years, affiliated to RSI, with rheumatoid arthritis treated with at least one DMARDS and/or biologic therapy

Exclusion Criteria:

  • patients under 18 years
  • Patients declared as rheumatoid arthritis without DMARDS or biologic therapy or treated with steroids alone
Contacts and Locations

Information from the National Library of Medicine

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): NCT01566851


Contacts
Contact: Liana EULLER-ZIEGLER, PU-PH 0033 4 92 03 55 12 euller-ziegler.l@chu-nice.fr
Contact: Véronique BREUIL, PU-PH 0033 4 92 03 55 12 breuil.v@chu-nice.fr

Sponsors and Collaborators
Centre Hospitalier Universitaire de Nice
Investigators
Principal Investigator: Liana EULLER-ZIEGLER, PU-PH CHU de Nice
More Information

Responsible Party: Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier: NCT01566851     History of Changes
Other Study ID Numbers: 12-01
First Posted: March 29, 2012    Key Record Dates
Last Update Posted: March 29, 2012
Last Verified: March 2012

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases