Early Rheumatoid Arthritis COR Intervention (ERACORI)

MD, PhD, Annemarie Lyng Svensson

Status: Enrolling

Conditions: Cardiovascular Diseases; Rheumatoid Arthritis

Treatments: Other: Outpatient rheumatology department; Other: Metformin; Other: Losartan; Other: Refered to general practice; Other: Simvastatin

Study type: Interventional

Funder types: Other

Identifiers

NCT02246257

OdenseUH

Details and patient eligibility

About

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.

Full 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).

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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300 participants in 2 patient groups

Intervention

Other group

Description:

In the intervention group all patients will receive statins according to national guidelines. Stepwise introduction of pharmacological therapy targeting 1) hyperlipidaemia, 2) hypertension, 3) hyperglycaemia and 4) microalbuminuria and behaviour modification will be controlled by the project team in an outpatient rheumatology department. Hyperlipidaemia: LDL \> 2.5 is treated with 40 mg Simvastatin; Hypertension: BT \> 140/90 mmHg treated with 100 mg OD Losartan; Diabetes: DM BT \> 130/80 mmHg treated with 100 mg OD Losartan; Microalbuminuria: Urinary albumin creatinin ratio \> 30 mg treated with 100 mg OD Losartan; Hyperglycaemia: HBA1C \> 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks Metformin

Treatment:

Other: Losartan

Other: Metformin

Other: Losartan

Other: Simvastatin

Other: Losartan

Other: Outpatient rheumatology department

Control

Other group

Description:

In the control group patients will be refered to general practice for pharmacological therapy according to national guidelines targeting 1) hyperlipidaemia, 2) hypertension, 3) hyperglycaemia and 4) microalbuminuria. Hyperlipidaemia: LDL \> 2.5 is treated with 40 mg Simvastatin; Hypertension: BT \> 140/90 mmHg treated with 100 mg OD Losartan; Diabetes: DM BT \> 130/80 mmHg treated with 100 mg OD Losartan; Microalbuminuria: Urinary albumin creatinin ratio \> 30 mg treated with 100 mg OD Losartan; Hyperglycaemia: HBA1C \> 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks Metformin

Treatment:

Other: Losartan

Other: Refered to general practice

Other: Metformin

Other: Losartan

Other: Simvastatin

Other: Losartan