Rheumatoid ArthritisCOTIRANCT07363980
Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study
An observational study of Rheumatoid Arthritis and Atherosclerotic Ischemic Disease, run by Ellen Margrethe Hauge at 4 sites in Denmark.
Trial summary
The Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis, Atherosclerotic Ischemic Disease, Pulmonary Disease
- How many people
- 4,000 participants
- Where
- 4 sitesDenmark
- Study dates
- 21 Feb 2024to 31 Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with rheumatoid arthritis from rheumatology outpatient clinics across Denmark.
Who may be able to join
- Fulfill the ACR/EULAR-2010 criteria for rheumatoid arthritis
- Attending or has attended at least one visit during the last two years in rheumatology outpatient clinic for diagnostic or monitoring purposes related to rheumatoid arthritis
- Age 50-75 years
Who cannot join
- Diagnosed with overlapping systemic autoimmune diseases other than secondary Sjogren's syndrome
- Active cancer
- Prior coronary atherosclerotic symptoms as defined by myocardial infraction, percutaneous coronary intervention, or coronary artery bypass grafting
- Allergy to radiocontrast agents
- Estimated glomerular filtration rate (eGFR) < 30 mL/min
- BMI > 35 kg/m2
- Persistent atrial fibrillation
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark4 sites
Aarhus University Hospital
Aarhus
Esbjerg Hospital
Esbjerg
Regional Hospital Gødstrup
Herning
Silkeborg Regional Hospital
Herning
About this study
The Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. It comprises a main protocol and several optional modules, including a Cardiac Imaging Module, Biobanking Module, Pulmonary Module, and Anxiety and Depression Module.
The study aims to advance understanding of cardiopulmonary and psychological comorbidities in rheumatoid arthritis, to improve early identification and management, and to enhance insights into underlying disease mechanisms-ultimately refining risk stratification and targeted prevention strategies.
The study includes 4,000 patients with rheumatoid arthritis enrolled through the Cardiac Imaging Module in the main protocol. Participants undergo coronary computed tomography angiography, pulmonary function testing, physical examination, questionnaires, and biobanking, supplemented by genetic, proteomic, metabolomic, and microbiome profiling.
Read the detailed description
This prospective, observational study follows individuals with rheumatoid arthritis over time to understand how the disease and its treatment relate to cardiovascular, pulmonary, psychological, and biological outcomes. The study collects standardized clinical data from outpatient rheumatology clinics, complemented by advanced imaging, biological sample collection, and linkage to national health registries.
Study Procedures and Visit Schedule Participants are enrolled during routine or ad-hoc outpatient visits. After informed consent, a baseline evaluation is performed, followed by standardized follow-up visits after approximately 3, 5, and 10 years (± 3-6 months).
At baseline, demographic and lifestyle factors (age, sex, education, smoking, alcohol, physical activity, and family history) are recorded together with anthropometric measures (height, weight, waist circumference) and rheumatoid arthritis characteristics (serologic status, disease duration, erosive disease, and disease activity scores). Concomitant diseases and medications are documented, and vital signs and blood pressure are measured.
Patient-reported outcomes include validated questionnaires on quality of life (Short Form 36, version 1), functional ability (Multidimensional Health Assessment Questionnaire), work productivity (Work Productivity and Activity Impairment - General Health), fatigue and pain visual analogue scales, physical activity (International Physical Activity Questionnaire - Short Form), and shortness of breath (University of California, San Diego Shortness of Breath Questionnaire). Laboratory results, including markers of inflammation and metabolic status, are obtained according to routine standards.
Follow-up visits repeat these assessments to evaluate disease activity, lifestyle changes, and incident comorbidities. Events such as hospitalizations, procedures, and deaths are continuously updated through registry linkage, ensuring complete longitudinal follow-up.
Registry Data Sources All participants are linked to national Danish health and administrative registries to enable comprehensive, long-term follow-up. The study integrates data from the National Patient Registry, the Danish Rheumatology Quality Database, the Civil Registration System, the Danish National Causes of Death Registry, the Western Denmark Heart Registry, the Danish Heart Registry, the Danish Stroke Registry, the Danish National Vascular Registry, the Danish National Database of Reimbursed Prescriptions, the Clinical Laboratory Information System, the Register of Laboratory Results for Research, and the Danish Research Institute for Economic Analysis and Modelling. Linkage across these registries allows continuous capture of clinical events, treatments, and vital status, ensuring complete longitudinal follow-up and verification of outcomes recorded during study visits.
Governance The study is governed by an executive steering committee responsible for overall scientific direction, study design, resource allocation, and regulatory compliance. Supporting boards and advisory groups contribute to patient involvement, methodological quality, and international collaboration. Dedicated centers coordinate site operations, biobanking, cardiac imaging, and data analysis to ensure standardized procedures and data integrity across all participating sites.
All procedures are conducted in accordance with Danish and European data-protection regulations, and data are stored and managed in secure systems compliant with the General Data Protection Regulation.
- Conditions
- Rheumatoid Arthritis, Atherosclerotic Ischemic Disease, Pulmonary Disease, Depressive Disorder, Anxiety Disorders, Cardiovascular and Respiratory Disease
- Keywords
- Coronary Computed Tomography Angiography, Pulmonary function tests, Biobank, Faecal microbiome, Patient reported outcomes, Genome sequencing, RNA sequencing, Epigenom sequencing, Coronary Artery Calcium Score, Proteomics, Metabolomics, Lipidomics, Multi-omics, Patient-reported outcomes, Disease Activity Score-28 for Rheumatoid Arthritis, Deep phenotyping, Coronary plaque analysis
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Depressive Disorder, Anxiety Disorders, Respiration Disorders, Cardiovascular Diseases, Pulmonary Disease, Chronic Obstructive, Lung Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with a first occurrence of Major Adverse Cardiovascular Events (MACE)
- Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death
- Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG
- Hospitalization for non-fatal ischemic stroke
Measured: 3, 5 and 10 years
Number of participants with a first occurrence of any ischemic cardiovascular events, including MACE
Hospitalization for cerebrovascular disease (transient ischemic attack). Hospitalization for peripheral vascular disease. Hospitalization for peripheral vascular surgery. Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death. Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG. Hospitalization for non-fatal ischemic stroke
Measured: 3, 5 and 10 years
Number of participants with all-cause death (all-cause mortality)
Death from any cause
Measured: 3, 5 and 10 years
Secondary outcomes (34)
Coronary Artery Calcium Score (Agatston score)
Coronary Artery Calcium Score (CACS), Agatston units. Minimum: 0. Maximum: No upper limit. Higher score indicates worse outcome (more coronary artery calcification).
Measured: Baseline
The coronary artery plaque surface extent at baseline evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques
Quantitative plaque measurement
Measured: Baseline
Change in Coronary Artery Calcium Score (Agatston units) from baseline to 3 years
Coronary Artery Calcium Score (Agatston score), Agatston units. Change (Δ) in Coronary Artery Calcium Score (CACS) calculated as 3-year CACS minus baseline CACS. Minimum: No lower limit (negative). Maximum: No upper limit (positive). A positive change indicates increasing calcification (worse); a negative change indicates decreasing calcification (better).
Measured: Baseline and 3 years
The quantitative difference in coronary artery plaque surface extent from baseline to 3 years evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques
Quantitative plaque measurement
Measured: Baseline and 3 year
Number of participants with a occurrence of hospitalization for cerebrovascular disease
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for non-fatal myocardial infarction
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for non-fatal ischemic stroke
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for peripheral vascular disease
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for peripheral vascular surgery
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for thromboembolic events as defined by deep vein thrombosis and pulmonary embolism
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for PCI
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for CABG
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a first occurrence of treatment for stable angina pectoris
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of treatment for atrial fibrillation and flutter
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with sudden death
Source of data: record and registry
Measured: 3, 5 and 10 years
Number of participants with cardiovascular death
Source of data: record and registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of treatment for essential hypertension with/without complications
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of treatment for disorders of lipoprotein metabolism and other lipidemias
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of treatment for diabetes mellitus
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for respiratory disease
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for interstitial pulmonary diseases
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for chronic lower respiratory diseases
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for anxiety disorders, including generalized anxiety disorder
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for a depressive episode or recurrent major depressive disorder
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of general practitioner-initiated treatment for anxiety disorders
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of general practitioner-initiated treatment for depression
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of referral to a psychologist or psychiatrist
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of infection with Mycobacterium tuberculosis
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of opportunistic infections
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for infections (suspected/confirmed)
Source of data: patient, record, registry
Measured: 3, 5 and 10 years
Proteomics concentrations
Blood sample
Measured: Baseline, 3, 5 and 10 years
Metabolomics concentration
Blood and stool sample
Measured: Baseline, 3, 5 and 10 years
Microbiome profile of stool
Stool sample
Measured: Baseline, 3, 5 and 10 years
Genome-, epigenom-, and RNA sequencing
Blood sample
Measured: Baseline, 3, 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start21 Feb 2024
- Primary completion31 Dec 2038 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ellen Margrethe Hauge
- Sponsor type
- University, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital, Independent Research Fund Denmark, Alfasigma S.p.A., ATACC-RD consortium, The Danish Rheumatism Association
- Responsible party
- Sponsor-investigator, Ellen Margrethe Hauge, University of Aarhus
- Investigators
- Ellen-Margrethe Hauge, MD, PhD, Study chair, Aarhus University Hospital and Aarhus UniversityDzenan Masic, MD, PhD, Study director, Aarhus University Hospital and Aarhus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07363980
- Sponsor's protocol ID
- 1-10-72-85-23
- Acronym
- COTIRA
- Status last verified
- Jan 2026
- First submitted
- 15 Jan 2026
- Last updated
- 3 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All IPD collected throughout the study.
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coronary Computed Tomography Angiography In Rheumatoid Arthritis Study
- ClinicalTrials.gov ID
- NCT07363980
- Acronym / sponsor ID
- COTIRA / 1-10-72-85-23
- Conditions
- Rheumatoid Arthritis, Atherosclerotic Ischemic Disease, Pulmonary Disease, Depressive Disorder, Anxiety Disorders, Cardiovascular and Respiratory Disease
- Keywords
- Coronary Computed Tomography Angiography, Pulmonary function tests, Biobank, Faecal microbiome, Patient reported outcomes, Genome sequencing, RNA sequencing, Epigenom sequencing
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Ellen Margrethe HaugeUniversity, hospital or other
- Collaborators
- University of Aarhus, Aarhus University Hospital, Independent Research Fund Denmark, Alfasigma S.p.A., ATACC-RD consortium, The Danish Rheumatism Association
- Study start
- 21 Feb 2024 (actual)
- Primary completion
- 31 Dec 2038 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 23 Jan 2026 (actual)
- 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 Coronary Computed Tomography Angiography in Rheumatoid Arthritis study is part of the multinational, prospective, observational Autoimmunity and Atherosclerosis in Rheumatic Diseases cohort (https://atacc-rd.com) that includes comprehensive baseline and follow-up assessments at 3, 5, and 10 years. It comprises a main protocol and several optional modules, including a Cardiac Imaging Module, Biobanking Module, Pulmonary Module, and Anxiety and Depression Module.
The study aims to advance understanding of cardiopulmonary and psychological comorbidities in rheumatoid arthritis, to improve early identification and management, and to enhance insights into underlying disease mechanisms-ultimately refining risk stratification and targeted prevention strategies.
The study includes 4,000 patients with rheumatoid arthritis enrolled through the Cardiac Imaging Module in the main protocol. Participants undergo coronary computed tomography angiography, pulmonary function testing, physical examination, questionnaires, and biobanking, supplemented by genetic, proteomic, metabolomic, and microbiome profiling.
Detailed description
This prospective, observational study follows individuals with rheumatoid arthritis over time to understand how the disease and its treatment relate to cardiovascular, pulmonary, psychological, and biological outcomes. The study collects standardized clinical data from outpatient rheumatology clinics, complemented by advanced imaging, biological sample collection, and linkage to national health registries.
Study Procedures and Visit Schedule Participants are enrolled during routine or ad-hoc outpatient visits. After informed consent, a baseline evaluation is performed, followed by standardized follow-up visits after approximately 3, 5, and 10 years (± 3-6 months).
At baseline, demographic and lifestyle factors (age, sex, education, smoking, alcohol, physical activity, and family history) are recorded together with anthropometric measures (height, weight, waist circumference) and rheumatoid arthritis characteristics (serologic status, disease duration, erosive disease, and disease activity scores). Concomitant diseases and medications are documented, and vital signs and blood pressure are measured.
Patient-reported outcomes include validated questionnaires on quality of life (Short Form 36, version 1), functional ability (Multidimensional Health Assessment Questionnaire), work productivity (Work Productivity and Activity Impairment - General Health), fatigue and pain visual analogue scales, physical activity (International Physical Activity Questionnaire - Short Form), and shortness of breath (University of California, San Diego Shortness of Breath Questionnaire). Laboratory results, including markers of inflammation and metabolic status, are obtained according to routine standards.
Follow-up visits repeat these assessments to evaluate disease activity, lifestyle changes, and incident comorbidities. Events such as hospitalizations, procedures, and deaths are continuously updated through registry linkage, ensuring complete longitudinal follow-up.
Registry Data Sources All participants are linked to national Danish health and administrative registries to enable comprehensive, long-term follow-up. The study integrates data from the National Patient Registry, the Danish Rheumatology Quality Database, the Civil Registration System, the Danish National Causes of Death Registry, the Western Denmark Heart Registry, the Danish Heart Registry, the Danish Stroke Registry, the Danish National Vascular Registry, the Danish National Database of Reimbursed Prescriptions, the Clinical Laboratory Information System, the Register of Laboratory Results for Research, and the Danish Research Institute for Economic Analysis and Modelling. Linkage across these registries allows continuous capture of clinical events, treatments, and vital status, ensuring complete longitudinal follow-up and verification of outcomes recorded during study visits.
Governance The study is governed by an executive steering committee responsible for overall scientific direction, study design, resource allocation, and regulatory compliance. Supporting boards and advisory groups contribute to patient involvement, methodological quality, and international collaboration. Dedicated centers coordinate site operations, biobanking, cardiac imaging, and data analysis to ensure standardized procedures and data integrity across all participating sites.
All procedures are conducted in accordance with Danish and European data-protection regulations, and data are stored and managed in secure systems compliant with the General Data Protection Regulation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with rheumatoid arthritis from rheumatology outpatient clinics across Denmark.
Key inclusion criteria (3 listed)
- Fulfill the ACR/EULAR-2010 criteria for rheumatoid arthritis
- Attending or has attended at least one visit during the last two years in rheumatology outpatient clinic for diagnostic or monitoring purposes related to rheumatoid arthritis
- Age 50-75 years
Key exclusion criteria (7 listed)
- Diagnosed with overlapping systemic autoimmune diseases other than secondary Sjogren's syndrome
- Active cancer
- Prior coronary atherosclerotic symptoms as defined by myocardial infraction, percutaneous coronary intervention, or coronary artery bypass grafting
- Allergy to radiocontrast agents
- Estimated glomerular filtration rate (eGFR) < 30 mL/min
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants with a first occurrence of Major Adverse Cardiovascular Events (MACE)
Time frame: 3, 5 and 10 years
1. Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death 2. Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG 3. Hospitalization for non-fatal ischemic stroke
Number of participants with a first occurrence of any ischemic cardiovascular events, including MACE
Time frame: 3, 5 and 10 years
Hospitalization for cerebrovascular disease (transient ischemic attack). Hospitalization for peripheral vascular disease. Hospitalization for peripheral vascular surgery. Cardiovascular death as defined by death from any of the following causes: Ischemic heart disease; Sudden cardiac death; Ventricular tachycardia; Other cardiac arrhythmias; Heart failure; Fatal ischemic stroke; Sudden undefined death; Unwitnessed or unknown cause of death. Hospitalization for non-fatal myocardial infarction, including hospitalization for PCI and CABG. Hospitalization for non-fatal ischemic stroke
Number of participants with all-cause death (all-cause mortality)
Time frame: 3, 5 and 10 years
Death from any cause
34 secondary outcomes
Coronary Artery Calcium Score (Agatston score)
Time frame: Baseline
The coronary artery plaque surface extent at baseline evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques
Time frame: Baseline
Change in Coronary Artery Calcium Score (Agatston units) from baseline to 3 years
Time frame: Baseline and 3 years
The quantitative difference in coronary artery plaque surface extent from baseline to 3 years evaluated for the percent composition of non-calcified-, mixed-, and calcified plaques
Time frame: Baseline and 3 year
Number of participants with a occurrence of hospitalization for cerebrovascular disease
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for non-fatal myocardial infarction
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for non-fatal ischemic stroke
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for peripheral vascular disease
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for peripheral vascular surgery
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for thromboembolic events as defined by deep vein thrombosis and pulmonary embolism
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for PCI
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of hospitalization for CABG
Time frame: 3, 5 and 10 years
Number of participants with a first occurrence of treatment for stable angina pectoris
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for atrial fibrillation and flutter
Time frame: 3, 5 and 10 years
Number of participants with sudden death
Time frame: 3, 5 and 10 years
Number of participants with cardiovascular death
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for essential hypertension with/without complications
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for disorders of lipoprotein metabolism and other lipidemias
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of treatment for diabetes mellitus
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for respiratory disease
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for interstitial pulmonary diseases
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for chronic lower respiratory diseases
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for anxiety disorders, including generalized anxiety disorder
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization or specialist-initiated treatment for a depressive episode or recurrent major depressive disorder
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of general practitioner-initiated treatment for anxiety disorders
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of general practitioner-initiated treatment for depression
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of referral to a psychologist or psychiatrist
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of infection with Mycobacterium tuberculosis
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of opportunistic infections
Time frame: 3, 5 and 10 years
Number of participants with a occurrence of hospitalization for infections (suspected/confirmed)
Time frame: 3, 5 and 10 years
Proteomics concentrations
Time frame: Baseline, 3, 5 and 10 years
Metabolomics concentration
Time frame: Baseline, 3, 5 and 10 years
Microbiome profile of stool
Time frame: Baseline, 3, 5 and 10 years
Genome-, epigenom-, and RNA sequencing
Time frame: Baseline, 3, 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2026.
- Individual participant dataSharing planned: Yes. All IPD collected throughout the study.
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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.
Ellen-Margrethe Hauge, MD, PhD study chair
Aarhus University Hospital and Aarhus University
Dzenan Masic, MD, PhD study director
Aarhus University Hospital and Aarhus University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis and Atherosclerotic Ischemic Disease, run by Ellen Margrethe Hauge at 4 sites 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 3 inclusion and 7 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: enrolling by invitation, as of the sponsor's last update on 3 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with a first occurrence of Major Adverse Cardiovascular Events (MACE) (time frame: 3, 5 and 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2026; AzTrials last refreshed its copy on 26 Oct 2026.