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UNKNOWNNANCT02246257

Early Rheumatoid Arthritis COR Intervention

The primary aim of our present study is to evaluate the effect of a targeted, intensified, multidimensional intervention compared to conventional treatment of modifiable risk factors for CVD in patien...

Lead sponsor: MD, PhD, Annemarie Lyng Svensson•1 locations•View source on ClinicalTrials.gov

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Contacts

Annemarie L Svensson, MD, PhD

CONTACT

+45 28 555 126 [email protected]

Torkell J Ellingsen, MD, PhD

CONTACT

+45 6541 1814 [email protected]

Sponsors

Lead Sponsor

MD, PhD, Annemarie Lyng Svensson

The study is a prospective randomised open, blinded endpoint trial with balanced randomisation (1:1) conducted in seven outpatient clinics in Denmark. Follow-up visits for patients in the intervention group are scheduled to occur at baseline and then after 2, 4 and 12 weeks and thereafter every third month for 5 years after randomisation. The control group will be monitored for RA disease activity and comorbidity after 2, 4 weeks, 12 weeks and thereafter following national guidelines for RA. Prevention of CVD risk factors in the control group will be treated in general practice according to national guidelines for diabetes (2011), hypertension (2009) and CVD (2013).

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL \> 2.5mmol/l.

Exclusion Criteria

•Pregnancy
•Lactation
•Ongoing/previous DMARD therapy
•Ongoing/previous steorid therapy
•Contraindication to any of the trial drugs
•Current infection with parvovirus B19, hepatitis B, hepatitis C or human immune deficiency virus. Previous report of hospitalisation for myocardial ischaemia defined as follows: a) non-fatal myocardial infarction (MI) defined according to national and international guidelines. b) Acute coronary syndrome (ACS) including acute ischaemic symptoms with possible biomarker changes or elctrocardiographic changes that to not meet the criteria for MI, c) angina pectoris, d) revascularisation (percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG).

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: May 23, 2022Terms

Trial snapshot

StatusUNKNOWN

PhaseNA

Enrollment300

Start dateSep 2014

Last updatedMay 23, 2022

Condition

Rheumatoid Arthritis Cardiovascular Diseases

Locations shown

Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital

Frederiksberg, Region of Copenhagen

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 23, 2022Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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