Clinical trial NCT02246257: Early Rheumatoid Arthritis COR Intervention
Official title: Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rheumatoid Arthritis
Cardiovascular Diseases
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed 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).

Eligibility criteria: 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).

Primary outcomes:
measure: Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Time to Death Due to Any Cause
timeFrame: Up to 5 years
measure: Time to Non-cardiovascular Death
timeFrame: Up to 5 years
measure: Time to Serious Adverse Event (hospitalizations)
timeFrame: Up to 5 years
measure: The proportion of patients having a treatment success
timeFrame: 1, 2 and 5 years
Other outcomes:
Locations:
city: Frederiksberg
country: Denmark
facility: Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital
state: Region Of Copenhagen
Study officials:
affiliation: Odense University Hospital
name: Torkell J Ellingsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Svensson AL, Christensen R, Persson F, Logstrup BB, Giraldi A, Graugaard C, Fredberg U, Blegvad J, Thygesen T, Hansen IM, Colic A, Bagdat D, Ahlquist P, Jensen HS, Horslev-Petersen K, Sheetal E, Christensen TG, Svendsen L, Emmertsen H, Ellingsen T. Multifactorial intervention to prevent cardiovascular disease in patients with early rheumatoid arthritis: protocol for a multicentre randomised controlled trial. BMJ Open. 2016 Apr 20;6(4):e009134. doi: 10.1136/bmjopen-2015-009134.