Early Rheumatoid Arthritis COR Intervention

Last updated: May 20, 2022
Sponsor: MD, PhD, Annemarie Lyng Svensson
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arthritis And Arthritic Pain

Joint Injuries

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT02246257
OdenseUH
  • Ages > 18
  • All Genders

Study Summary

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 patients with early RA. The primary endpoint, a composite of death from cardiovascular causes, non-fatal MI, non-fatal stroke and re-vascularisation, will be assessed after 5years' follow-up.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 immunedeficiency virus. Previous report of hospitalisation for myocardial ischaemia definedas follows: a) non-fatal myocardial infarction (MI) defined according to national andinternational guidelines. b) Acute coronary syndrome (ACS) including acute ischaemicsymptoms with possible biomarker changes or elctrocardiographic changes that to notmeet the criteria for MI, c) angina pectoris, d) revascularisation (percutaneouscoronary intervention (PCI) or coronary artery bypass grafting (CABG).

Study Design

Total Participants: 300
Study Start date:
September 01, 2014
Estimated Completion Date:
September 30, 2024

Study Description

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).

Connect with a study center

  • Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital

    Frederiksberg, Region Of Copenhagen 2000
    Denmark

    Active - Recruiting

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