Short summary

This is a prospective, randomised, open label trial with blinded end point assessment and balanced randomisation (1:1) in 9 outpatient clinics in Denmark. The primary end point after 5 years of follow-up is a composite of death from cardiovascular causes, nonfatal MI, non-fatal stroke and cardiac revascularisation. Secondary outcomes: the proportion of patients achieving LDL- cholesterol <2.5 mmol/L, glycated haemoglobin <48 mmol/mol, BP<140/90 mm Hg for patients without diabetes (DM) and <130/

Rationale

Cardiovascular morbidity is a major burden in patients with rheumatoid arthritis (RA). In this study, we compare the effect of a targeted, intensified, multifactorial intervention with that of conventional treatment of modifiable risk factors for cardiovascular disease (CVD) in pa-tients with early RA fulfilling the 2010 American College of Rheumatology European League Against Rheumatism (ACR/EULAR) criteria.

Description of the cohort

The participants in the study have RA diagnosed by the treating rheumatologist. Key inclusion criteria: RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma low-density lipoprotein (LDL) >2.5 mmol/L. Study participants were recruited from 7 hospital outpatient clinics in Frederiksberg, Glostrup, Odense, Aalborg, Svendborg, Køge og Gråsten and Reumaclinic Fyn and Reumaclinic Roskilde

Data and biological material

Demographic, questionnaire data, blood samples and tender and swollen joints are from DANBIO the nationwide Danish clinical register for patients with rheumatoid artritis. Cardio-vascular disease outcomes, hospitalization and death are data from the patient record.

Collaborating researchers and departments

Department of Rheumatology, Odense university hospital

• Professor Torkell Ellingsen

Publications associated with the project

Svensson AL, Christensen R, Persson F, et al. Multifactorial intervention to prevent cardio-vasular disease in patients with early rheumatoid arthritis: protocol for a multicentre ran-domized controlled trial. BMJ Open 2016;6:e009134.