Rheumatoid ArthritisERACORINCT02246257
Early Rheumatoid Arthritis COR Intervention
A study testing Simvastatin, Losartan and Metformin in people with Rheumatoid Arthritis and Cardiovascular Diseases, run by MD, PhD, Annemarie Lyng Svensson at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis, Cardiovascular Diseases
- What is being tested?
- Simvastatin, Losartan and Metformin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteDenmark
- Study dates
- Sep 2014to Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL > 2.5mmol/l.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Denmark1 site, 1 recruiting
- Recruiting
Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital
Frederiksberg, Region of Copenhagen, 2000
Annemarie Lyng Svesson, MD, PhD, 004528555126, lyng.annemarie@gmail.com
Torkell J Ellingsen, MD, PhD, Professor, 004565413523, torkell.ellingsen@rsyd.dk
About this study
Official title: Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
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.
Read the 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).
- Conditions
- Rheumatoid Arthritis, Cardiovascular Diseases
- Being tested
- Simvastatin, Losartan, Metformin, Outpatient rheumatology department, Refered to general practice
- Medical subject headings
- Arthritis, Rheumatoid, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SimvastatinOther
Also called Hyperlipidaemia
LDL > 2.5 is treated with 40 mg
LosartanOther
Also called Hypertension
BT > 140/90 mmHg treated with 50 mg OD
LosartanOther
Also called Diabetes
DM BT > 130/80 mmHg treated with 50 mg OD
LosartanOther
Also called Microalbuminuria
Microalbuminuria (urinary albumin creatinin ratio > 30 mg) treated with 100 mg OD
MetforminOther
Also called Hyperglycaemia
HBA1C > 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks
Outpatient rheumatology departmentOther
Also called Intervention
(4 times yearly)
Refered to general practiceOther
Also called Control
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Other | 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 Receives: Other: Simvastatin; Other: Losartan; Other: Metformin; Other: Outpatient rheumatology department |
| Control | Other | 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 Receives: Other: Simvastatin; Other: Losartan; Other: Metformin; Other: Refered to general practice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Major Cardiac Event (death from cardiovascular causes, non-fatal myocardial infarction, non-fatal stroke and cardiac revascularization)
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.
Measured: Up to 5 years
Secondary outcomes (4)
Time to Death Due to Any Cause
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
Measured: Up to 5 years
Time to Non-cardiovascular Death
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
Measured: Up to 5 years
Time to Serious Adverse Event (hospitalizations)
Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean
Measured: Up to 5 years
The proportion of patients having a treatment success
- 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
Measured: 1, 2 and 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MD, PhD, Annemarie Lyng Svensson
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, MD, PhD, Annemarie Lyng Svensson, Odense University Hospital
- Investigators
- Torkell J Ellingsen, MD, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246257
- Sponsor's protocol ID
- OdenseUH
- Acronym
- ERACORI
- Status last verified
- May 2022
- First submitted
- 17 Sep 2014
- Last updated
- 23 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 27098820
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02246257
- Acronym / sponsor ID
- ERACORI / OdenseUH
- Conditions
- Rheumatoid Arthritis, Cardiovascular Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- MD, PhD, Annemarie Lyng SvenssonUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 22 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Other | Other: Simvastatin, Other: Losartan, Other: Metformin, Other: Outpatient rheumatology departmentIn 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 |
| Control | Other | Other: Simvastatin, Other: Losartan, Other: Metformin, Other: Refered to general practiceIn 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL > 2.5mmol/l.
Key exclusion criteria (6 listed)
- Pregnancy
- Lactation
- Ongoing/previous DMARD therapy
- Ongoing/previous steorid therapy
- Contraindication to any of the trial drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SimvastatinAlso: HyperlipidaemiaLDL > 2.5 is treated with 40 mg | Other | Control, Intervention |
| LosartanAlso: HypertensionBT > 140/90 mmHg treated with 50 mg OD | Other | Control, Intervention |
| LosartanAlso: DiabetesDM BT > 130/80 mmHg treated with 50 mg OD | Other | Control, Intervention |
| LosartanAlso: MicroalbuminuriaMicroalbuminuria (urinary albumin creatinin ratio > 30 mg) treated with 100 mg OD | Other | Control, Intervention |
| MetforminAlso: HyperglycaemiaHBA1C > 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks | Other | Control, Intervention |
| Outpatient rheumatology departmentAlso: Intervention(4 times yearly) | Other | Intervention |
| Refered to general practiceAlso: Control | Other | Control |
Primary outcome
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.
4 secondary outcomes
Time to Death Due to Any Cause
Time frame: Up to 5 years
Time to Non-cardiovascular Death
Time frame: Up to 5 years
Time to Serious Adverse Event (hospitalizations)
Time frame: Up to 5 years
The proportion of patients having a treatment success
Time frame: 1, 2 and 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2022.
- Derived from this study: PubMed 27098820Svensson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Torkell J Ellingsen, MD, PhD principal investigator
Odense University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Simvastatin, Losartan and Metformin in people with Rheumatoid Arthritis and Cardiovascular Diseases, run by MD, PhD, Annemarie Lyng Svensson at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Annemarie L Svensson, MD, PhD (+45 28 555 126, lyng.annemarie@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02246257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2022.