Clinical trial NCT01566851: Application of EULAR Recommendations for Cardiovascular Risk Management in Patients With Rheumatoid Arthritis
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 type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Check-up in Patients With Rheumatoid Arthritis
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 7000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis

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.


Eligibility 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

Primary outcomes:
measure: the following items use in the evaluation of the cardiovascular risk factors
timeFrame: at time = 2 years
Secondary outcomes:
measure: the following items use in the evaluation of the cardiovascular risk factors on the sub population
timeFrame: t=0 and t=2 years
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Liana EULLER-ZIEGLER, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: