Ignite Creation Date:
2025-12-24 @ 6:55 PM
Ignite Modification Date:
2026-01-18 @ 12:39 PM
Study NCT ID:
NCT02246257
Status:
UNKNOWN
Last Update Posted:
2022-05-23
First Post:
2014-09-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Rheumatoid Arthritis COR Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001172', 'term': 'Arthritis, Rheumatoid'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}], 'ancestors': [{'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019821', 'term': 'Simvastatin'}, {'id': 'D019808', 'term': 'Losartan'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'D008722', 'term': 'Methods'}], 'ancestors': [{'id': 'D008148', 'term': 'Lovastatin'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D001713', 'term': 'Biphenyl Compounds'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D007093', 'term': 'Imidazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D013777', 'term': 'Tetrazoles'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-05', 'completionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-05-20', 'studyFirstSubmitDate': '2014-09-17', 'studyFirstSubmitQcDate': '2014-09-18', 'lastUpdatePostDateStruct': {'date': '2022-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Time to Death Due to Any Cause', 'timeFrame': 'Up to 5 years', 'description': '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'}, {'measure': 'Time to Non-cardiovascular Death', 'timeFrame': 'Up to 5 years', 'description': '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'}, {'measure': 'Time to Serious Adverse Event (hospitalizations)', 'timeFrame': 'Up to 5 years', 'description': 'Time from randomization to the first venous thromboembolic event. Kaplan-Meier estimate of the mean'}, {'measure': 'The proportion of patients having a treatment success', 'timeFrame': '1, 2 and 5 years', 'description': '* LDL cholesterol \\< 2.5 mmol/l\n* HbA1c \\< 48 mmol/mol (HbA1c \\< 6.5%),\n* 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.\n* 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'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rheumatoid Arthritis', 'Cardiovascular Diseases']}, 'referencesModule': {'references': [{'pmid': '27098820', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* RA according to the revised American College of Rheumatology (ACR) 2010 criteria and plasma LDL \\> 2.5mmol/l.\n\nExclusion Criteria:\n\n* Pregnancy\n* Lactation\n* Ongoing/previous DMARD therapy\n* Ongoing/previous steorid therapy\n* Contraindication to any of the trial drugs\n* 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).'}, 'identificationModule': {'nctId': 'NCT02246257', 'acronym': 'ERACORI', 'briefTitle': 'Early Rheumatoid Arthritis COR Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Odense University Hospital'}, 'officialTitle': 'Multifactorial Intervention to Prevent Cardiovascular Disease in Patients With Early Rheumatoid Arthritis', 'orgStudyIdInfo': {'id': 'OdenseUH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Intervention', '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.\n\nHyperlipidaemia: 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', 'interventionNames': ['Other: Simvastatin', 'Other: Losartan', 'Other: Metformin', 'Other: Outpatient rheumatology department']}, {'type': 'OTHER', 'label': 'Control', '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.\n\nHyperlipidaemia: 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', 'interventionNames': ['Other: Simvastatin', 'Other: Losartan', 'Other: Metformin', 'Other: Refered to general practice']}], 'interventions': [{'name': 'Simvastatin', 'type': 'OTHER', 'otherNames': ['Hyperlipidaemia'], 'description': 'LDL \\> 2.5 is treated with 40 mg', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Losartan', 'type': 'OTHER', 'otherNames': ['Hypertension'], 'description': 'BT \\> 140/90 mmHg treated with 50 mg OD', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Losartan', 'type': 'OTHER', 'otherNames': ['Diabetes'], 'description': 'DM BT \\> 130/80 mmHg treated with 50 mg OD', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Losartan', 'type': 'OTHER', 'otherNames': ['Microalbuminuria'], 'description': 'Microalbuminuria (urinary albumin creatinin ratio \\> 30 mg) treated with 100 mg OD', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Metformin', 'type': 'OTHER', 'otherNames': ['Hyperglycaemia'], 'description': 'HBA1C \\> 48 mmol/mol treated with 500 mg increased dose to 2,000 mg in 4 weeks', 'armGroupLabels': ['Control', 'Intervention']}, {'name': 'Outpatient rheumatology department', 'type': 'OTHER', 'otherNames': ['Intervention'], 'description': '(4 times yearly)', 'armGroupLabels': ['Intervention']}, {'name': 'Refered to general practice', 'type': 'OTHER', 'otherNames': ['Control'], 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2000', 'city': 'Frederiksberg', 'state': 'Region of Copenhagen', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Annemarie Lyng Svesson, MD, PhD', 'role': 'CONTACT', 'email': 'lyng.annemarie@gmail.com', 'phone': '004528555126'}, {'name': 'Torkell J Ellingsen, MD, PhD, Professor', 'role': 'CONTACT', 'email': 'torkell.ellingsen@rsyd.dk', 'phone': '004565413523'}], 'facility': 'Department of Rheumathology, Frederiksberg and Bispebjerg univeristy Hospital', 'geoPoint': {'lat': 55.67938, 'lon': 12.53463}}], 'centralContacts': [{'name': 'Annemarie L Svensson, MD, PhD', 'role': 'CONTACT', 'email': 'lyng.annemarie@gmail.com', 'phone': '+45 28 555 126'}, {'name': 'Torkell J Ellingsen, MD, PhD', 'role': 'CONTACT', 'email': 'torkell.ellingsen@rsyd.dk', 'phone': '+45 6541 1814'}], 'overallOfficials': [{'name': 'Torkell J Ellingsen, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Odense University Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MD, PhD, Annemarie Lyng Svensson', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'MD, PhD, Annemarie Lyng Svensson', 'investigatorAffiliation': 'Odense University Hospital'}}}}