Rheumatoid Arthritis and Associated ConditionsAURORANCT05396469
Using Thoracic Ultrasound to Detect Interstitial Lung Disease in Patients With Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis and Associated Conditions and Lung Diseases, Interstitial, run by Torkell Ellingsen at 1 site in Denmark.
Trial summary
Background: Pulmonary diseases are significant contributors to morbidity and mortality in patients with rheumatoid arthritis (RA). One of the most common pulmonary manifestation in RA is interstitial lung disease (RA-ILD). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis and Associated Conditions, Lung Diseases, Interstitial
- What is being tested?
- National guideline treatment
- How many people
- 80 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jun 2022to 2 Jun 2023
- Phase
- Observational
- 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
Study population: Eligible patients will be recruited from the Department of Rheumatology in the Hospital of South West Jutland, Odense University Hospital - Svendborg Hospital, Lillebaelt Hospital and Odense University Hospital (OUH). Patients coming inn for a planned control of their RA disease and management, will be asked if they have respiratory symptoms. If respiratory symptoms are present, the patient will receive oral information about this project and those who are interested in participating, will receive written information as well as a signed consent form (not yet to be signed). Subsequently, the patients will be referred to the highly specialized unit in the Department of Rheumatology at OUH as well as a full clinical evaluation in the PUlmo-REuma (PURE) Clinic located at OUH.
Who may be able to join
- Patients eligible for inclusion are consenting adults (≥18 years) diagnosed with RA, with presence of at least one of the following symptoms: unexplained dyspnoea, unexplained cough, residual pneumonia or a chest X-ray indicating interstitial lung disease. All patients must fulfil the 2010 criteria for RA. A diagnosis of COPD does not exclude the patient from the study.
Who cannot join
- Patients with other systemic autoimmune diseases than RA (except secondary Sjøgrens syndrome) will be excluded. Other exclusion criteria are; previous or active lung cancer, lung transplant recipients and patients with known ILD or congenital lung disease, as well as patients who have had an HRCT performed within 12 months prior to the inclusion date. Patients who are unwilling or unable to provide written informed consent will also be excluded (i.e. not eligible).
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rheumatology Research Unit, Dept. of Rheumatology, OUH
Odense, 5000
About this study
Official title: Using Thoracic Ultrasound in a Rheumatological Setting to Detect Interstitial Lung Disease in Patients With Rheumatoid Arthritis: Protocol for a Cross-Sectional Diagnostic Test Accuracy Study. AURORA.
Background: Pulmonary diseases are significant contributors to morbidity and mortality in patients with rheumatoid arthritis (RA). One of the most common pulmonary manifestation in RA is interstitial lung disease (RA-ILD). Consequently, RA-ILD may be prevalent in approximately 30% and clinically evident in about 10% of RA patients. Since the median survival for patients with manifest RA-ILD is only 6.6 years, feasible methods of detecting early RA-ILD are warranted.
Objectives: To determine the diagnostic accuracy of thoracic ultrasound (TUS), using a 14-zone protocol, for ILD in RA patients with respiratory symptoms by using chest high-resolution computed tomography (HRCT) as the reference standard. The secondary aim is to evaluate the diagnostic accuracy for the blood biomarkers surfactant protein-D (SP-D) and microfibrillar-associated protein 4 (MFAP4) in the detection of ILD in this group of patients.
Read more
Data collection: Participants will be included after signing the informed consent; data will be collected and stored in a REDCap database.
Eligibility criteria for participants and settings where data will be collected: Patients eligible for inclusion are consenting adults (≥18 years) diagnosed with RA (according to the 2010 ACR-criteria for RA) and respiratory symptoms indicating RA-ILD, based on the presence of at least one of the following symptoms: unexplained dyspnoea, unexplained cough and/or a residual pneumonia or a chest X-ray indicating interstitial abnormalities in the lung.
Whether participants form a consecutive, random or convenience series: Participants form a consecutive series of up to 80 individuals in total.
Description of the index test and reference standard: Patients suspected of having RA-ILD will undergo a 14 zone TUS as index test performed by a junior resident in rheumatology, who is certified by the European Respiratory Society in performing TUS assessment. The anonymised images will be stored, and scored by the junior resident and two senior rheumatologists, who have also received training in TUS, as well as a TUS and ILD experienced pulmonologist. Chest HRCT will be the gold standard, i.e. the ILD reference standard.
Estimates of diagnostic accuracy and their precision: The two basic measures for quantifying the diagnostic accuracy of the TUS (index) test are the sensitivity and specificity in comparison to the chest HRCT. Statistical tests will be conducted using the McNemar test for correlated proportions.
- Being tested
- National guideline treatment
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
National guideline treatmentDiagnostic test
All discovered diseases will recieve national guideline treatment and follow up
What is being measured
The primary outcome is the main question the study is designed to answer.
RA-ILD
Estimates of diagnostic accuracy and precision: The diagnostic accuracy of the TUS (index) test for interstitial lung disease in rheumatoid arthritis in comparison to the chest HRCT.
Measured: 31.01.2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2022
- Study start10 Jun 2022
- Primary completion15 May 2023
- Study completion2 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis and Associated ConditionsStudies 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
- Cross-sectional
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Torkell Ellingsen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Torkell Ellingsen, Odense University Hospital
- Investigators
- Torkell Ellingsen, MD, PhD, Principal investigator, Odense University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05396469
- Sponsor's protocol ID
- S-20210154
- Acronym
- AURORA
- Status last verified
- Jun 2023
- First submitted
- 25 May 2022
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data from the AURORA study will be stored in the Danish Data Archive (DDA) when data have been analysed and published. Through an agreement with the Danish Data Protection agency, the DDA preserves data materials containing personal identifiers. Data and the personal identifiers will be stored separately and special permits are required for access to the data. Data will be available on request for academic researchers.
Publications
Sofiudottir BK, Harders S, Laursen CB, Lage-Hansen PR, Nielsen SM, Just SA, Christensen R, Davidsen JR, Ellingsen T. Detection of Interstitial Lung Disease in Rheumatoid Arthritis by Thoracic Ultrasound: A Diagnostic Test Accuracy Study. Arthritis Care Res (Hoboken). 2024 Sep;76(9):1294-1302. doi: 10.1002/acr.25351. Epub 2024 Jun 23.
PubMed 38622106Sofiudottir BK, Harders SMW, Lage-Hansen PR, Christensen R, Munk HL, Sorensen GL, Davidsen JR, Ellingsen T. Using thoracic ultrasound to detect interstitial lung disease in patients with rheumatoid arthritis: a protocol for the diagnostic test accuracy AURORA study. BMJ Open. 2022 Dec 23;12(12):e067434. doi: 10.1136/bmjopen-2022-067434.
PubMed 36564119
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Thoracic Ultrasound in a Rheumatological Setting to Detect Interstitial Lung Disease in Patients With Rheumatoid Arthritis: Protocol for a Cross-Sectional Diagnostic Test Accuracy Study. AURORA.
- ClinicalTrials.gov ID
- NCT05396469
- Acronym / sponsor ID
- AURORA / S-20210154
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Torkell EllingsenUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 15 May 2023 (actual)
- Study completion
- 2 Jun 2023 (actual)
- First posted
- 31 May 2022 (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.
Background: Pulmonary diseases are significant contributors to morbidity and mortality in patients with rheumatoid arthritis (RA). One of the most common pulmonary manifestation in RA is interstitial lung disease (RA-ILD). Consequently, RA-ILD may be prevalent in approximately 30% and clinically evident in about 10% of RA patients. Since the median survival for patients with manifest RA-ILD is only 6.6 years, feasible methods of detecting early RA-ILD are warranted.
Objectives: To determine the diagnostic accuracy of thoracic ultrasound (TUS), using a 14-zone protocol, for ILD in RA patients with respiratory symptoms by using chest high-resolution computed tomography (HRCT) as the reference standard. The secondary aim is to evaluate the diagnostic accuracy for the blood biomarkers surfactant protein-D (SP-D) and microfibrillar-associated protein 4 (MFAP4) in the detection of ILD in this group of patients.
Data collection: Participants will be included after signing the informed consent; data will be collected and stored in a REDCap database.
Eligibility criteria for participants and settings where data will be collected: Patients eligible for inclusion are consenting adults (≥18 years) diagnosed with RA (according to the 2010 ACR-criteria for RA) and respiratory symptoms indicating RA-ILD, based on the presence of at least one of the following symptoms: unexplained dyspnoea, unexplained cough and/or a residual pneumonia or a chest X-ray indicating interstitial abnormalities in the lung.
Whether participants form a consecutive, random or convenience series: Participants form a consecutive series of up to 80 individuals in total.
Description of the index test and reference standard: Patients suspected of having RA-ILD will undergo a 14 zone TUS as index test performed by a junior resident in rheumatology, who is certified by the European Respiratory Society in performing TUS assessment. The anonymised images will be stored, and scored by the junior resident and two senior rheumatologists, who have also received training in TUS, as well as a TUS and ILD experienced pulmonologist. Chest HRCT will be the gold standard, i.e. the ILD reference standard.
Estimates of diagnostic accuracy and their precision: The two basic measures for quantifying the diagnostic accuracy of the TUS (index) test are the sensitivity and specificity in comparison to the chest HRCT. Statistical tests will be conducted using the McNemar test for correlated proportions.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be recruited from the Department of Rheumatology in the Hospital of South West Jutland, Odense University Hospital - Svendborg Hospital, Lillebaelt Hospital and Odense University Hospital (OUH). Patients coming inn for a planned control of their RA disease and management, will be asked if they have respiratory symptoms. If respiratory symptoms are present, the patient will receive oral information about this project and those who are interested in participating, will receive written information as well as a signed consent form (not yet to be signed). Subsequently, the patients will be referred to the highly specialized unit in the Department of Rheumatology at OUH as well as a full clinical evaluation in the PUlmo-REuma (PURE) Clinic located at OUH.
Key inclusion criteria (1 listed)
- Patients eligible for inclusion are consenting adults (≥18 years) diagnosed with RA, with presence of at least one of the following symptoms: unexplained dyspnoea, unexplained cough, residual pneumonia or a chest X-ray indicating interstitial lung disease. All patients must fulfil the 2010 criteria for RA. A diagnosis of COPD does not exclude the patient from the study.
Key exclusion criteria (1 listed)
- Patients with other systemic autoimmune diseases than RA (except secondary Sjøgrens syndrome) will be excluded. Other exclusion criteria are; previous or active lung cancer, lung transplant recipients and patients with known ILD or congenital lung disease, as well as patients who have had an HRCT performed within 12 months prior to the inclusion date. Patients who are unwilling or unable to provide written informed consent will also be excluded (i.e. not eligible).
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 |
|---|---|---|
| National guideline treatmentAll discovered diseases will recieve national guideline treatment and follow up | Diagnostic test | – |
Primary outcome
RA-ILD
Time frame: 31.01.2024
Estimates of diagnostic accuracy and precision: The diagnostic accuracy of the TUS (index) test for interstitial lung disease in rheumatoid arthritis in comparison to the chest HRCT.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Derived from this study: PubMed 38622106Sofiudottir BK, Harders S, Laursen CB, Lage-Hansen PR, Nielsen SM, Just SA, Christensen R, Davidsen JR, Ellingsen T. Detection of Interstitial Lung Disease in Rheumatoid Arthritis by Thoracic Ultrasound: A Diagnostic Test Accuracy Study. Arthritis Care Res (Hoboken). 2024 Sep;76(9):1294-1302. doi: 10.1002/acr.25351. Epub 2024 Jun 23.
- Derived from this study: PubMed 36564119Sofiudottir BK, Harders SMW, Lage-Hansen PR, Christensen R, Munk HL, Sorensen GL, Davidsen JR, Ellingsen T. Using thoracic ultrasound to detect interstitial lung disease in patients with rheumatoid arthritis: a protocol for the diagnostic test accuracy AURORA study. BMJ Open. 2022 Dec 23;12(12):e067434. doi: 10.1136/bmjopen-2022-067434.
- Individual participant dataSharing planned: Yes. Data from the AURORA study will be stored in the Danish Data Archive (DDA) when data have been analysed and published. Through an agreement with the Danish Data Protection agency, the DDA preserves data materials containing personal identifiers. Data and the personal identifiers will be stored separately and special permits are required for access to the data. Data will be available on request for academic researchers.
Related trials for Rheumatoid Arthritis and Associated Conditions
RecruitingPhase 2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease
Sjogren's Syndrome
RecruitingObservational study
Collection of Airway, Blood and/or Urine Specimens From Subjects for Research Studies
Chronic Obstructive Pulmonary Disease (COPD), Smoking
RecruitingObservational study
Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research
Post-Acute COVID-19 Syndrome, ME/CFS
Not yet recruiting
A Study of CD19 UCAR-T Cells in Subjects With Autoimmune Diseases
Systemic Lupus Erythematosus, Idiopahic Inflammatory Myopathies
Active, not recruitingPhase 1/2
Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Syndrome
Sjogren's Syndrome
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 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?
An observational study of Rheumatoid Arthritis and Associated Conditions and Lung Diseases, Interstitial, run by Torkell Ellingsen 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 1 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: finished, as of the sponsor's last update on 18 Jun 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
RA-ILD (time frame: 31.01.2024). 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 NCT05396469, which also lists 2 linked publications.
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 18 Jun 2023.