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Early Rheumatoid Arthritis COR Intervention (ERACORI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02246257
Recruitment Status : Recruiting
First Posted : September 22, 2014
Last Update Posted : November 27, 2018
Sponsor:
Information provided by (Responsible Party):
MD, PhD, Annemarie Lyng Svensson, Odense University Hospital

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Cardiovascular Diseases Other: Simvastatin Other: Losartan Other: Metformin Other: Outpatient rheumatology department Other: Refered to general practice Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
Study Start Date : September 2014
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Intervention

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

Other: Simvastatin
LDL > 2.5 is treated with 40 mg
Other Name: Hyperlipidaemia

Other: Losartan
BT > 140/90 mmHg treated with 50 mg OD
Other Name: Hypertension

Other: Losartan
DM BT > 130/80 mmHg treated with 50 mg OD
Other Name: Diabetes

Other: Losartan
Microalbuminuria (urinary albumin creatinin ratio > 30 mg) treated with 100 mg OD
Other Name: Microalbuminuria

Other: Metformin
HBA1C > 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks
Other Name: Hyperglycaemia

Other: Outpatient rheumatology department
(4 times yearly)
Other Name: Intervention

Control

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

Other: Simvastatin
LDL > 2.5 is treated with 40 mg
Other Name: Hyperlipidaemia

Other: Losartan
BT > 140/90 mmHg treated with 50 mg OD
Other Name: Hypertension

Other: Losartan
DM BT > 130/80 mmHg treated with 50 mg OD
Other Name: Diabetes

Other: Losartan
Microalbuminuria (urinary albumin creatinin ratio > 30 mg) treated with 100 mg OD
Other Name: Microalbuminuria

Other: Metformin
HBA1C > 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks
Other Name: Hyperglycaemia

Other: Refered to general practice
Other Name: Control




Primary Outcome Measures :
  1. Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization) [ Time Frame: Up to 5 years ]
    Days from randomization to the first of cardiac event. If no event, censoring occurs at earliest of termination date or efficacy cut-off date of 31 December 2020. Events will be adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean.


Secondary Outcome Measures :
  1. Time to Death Due to Any Cause [ Time Frame: Up to 5 years ]
    Days from randomization to death. If no death then censoring occurs at earliest of termination date or efficacy cutoff date of 31 Dec 2020. Kaplan-Meier estimate of the mean

  2. Time to Non-cardiovascular Death [ Time Frame: Up to 5 years ]
    Days from randomization to death from a non-cardiovascular cause. If no event, then censoring occurs at earliest of termination date or efficacy cutoff date of 31 Dec 2020. Events will be adjudicated by an endpoint committee. Kaplan-Meier estimate of the mean

  3. Time to Serious Adverse Event (hospitalizations) [ Time Frame: Up to 5 years ]
    Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean

  4. The proportion of patients having a treatment success [ Time Frame: 1, 2 and 5 years ]
    • LDL cholesterol < 2.5 mmol/l
    • HbA1c < 48 mmol/mol (HbA1c < 6.5%),
    • Blood pressure < 140/90 mmHg for non-diabetic patients and < 130/80 mm Hg for diabetic patients and normoalbuminuria (urinary albumin creatinine ratio < 30 mg/g) after 1-year of follow-up this in agreement with present national guidelines, which will be adjusted accordingly to any future changes in the respective national guidelines.
    • Low RA disease activity DAS28-CRP < 3.2 and DAS28-CRP < 2.6 at 12, 24 and 60 months. Furthermore, all to hospitalisations will be adjudicated by the event committee



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02246257


Contacts
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Contact: Annemarie L Svensson, MD, PhD +45 28 555 126 lyng.annemarie@gmail.com
Contact: Torkell J Ellingsen, MD, PhD +45 6541 1814 torkell.ellingsen@rsyd.dk

Locations
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Denmark
Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital Recruiting
Frederiksberg, Region Of Copenhagen, Denmark, 2000
Contact: Annemarie Lyng Svesson, MD, PhD    004528555126    lyng.annemarie@gmail.com   
Contact: Torkell J Ellingsen, MD, PhD, Professor    004565413523    torkell.ellingsen@rsyd.dk   
Sponsors and Collaborators
MD, PhD, Annemarie Lyng Svensson
Investigators
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Principal Investigator: Torkell J Ellingsen, MD, PhD Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: MD, PhD, Annemarie Lyng Svensson, MD, PhD, Odense University Hospital
ClinicalTrials.gov Identifier: NCT02246257    
Other Study ID Numbers: OdenseUH
First Posted: September 22, 2014    Key Record Dates
Last Update Posted: November 27, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Cardiovascular Diseases
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Metformin
Losartan
Simvastatin
Hypoglycemic Agents
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists