dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound (NCT06235645) | Clinical Trial Compass
RecruitingNot Applicable
dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound
France280 participantsStarted 2024-11-18
Plain-language summary
Rheumatoid arthritis is an autoimmune disease that can affect various organs, including the lungs, and lead to rheumatoid arthritis-interstitial lung disease (RA-ILD).
RA-ILD is responsible for increased mortality in rheumatoid arthristis (RA) patients.
The prevalence of RA-ILD varies according to the screening tool used.
The current gold standard is chest CT, but this is an expensive, time-consuming and irradiating examination, and recommendations on when and how often it should be performed are not clearly established.
Lung ultrasound (LUS) is an emerging tool for the detection of lung parenchymal damage, particularly in systemic scleroderma and idiopathic pulmonary fibrosis (IPF).
LUS is a non-irradiating, non-expensive examination that can be performed rapidly.
The aim of our study is to evaluate LUS as a screening tool for RA-ILD, in patients with risk factors for developing RA-ILD.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adult patient (age \> 18 years) followed at CHU of Tours
* Diagnosis of rheumatoid arthritis validated according to ACR 2010 criteria, EULAR classification, regardless of time since diagnosis
* Patient who has had or will have a thoracic CT scan and PFT performed as part of routine care in the 6 months preceding or following inclusion
* Patient with at least two risk factors for developing RA-ILD among :
* Male sex or
* Active or former smoker assessed at 20 pack-year or
* Age \> 60 years or
* Levels of RF≥3N (rheumatoid factor) and/or anti-CCP≥3N (antibodies against cyclic citrullinated peptides) at diagnosis or at any time during the course of the disease or
* High RA activity score (DAS28\>3.2)
Exclusion Criteria:
* Diagnosis of congenital lung disease
* Diagnosis of another autoimmune pathology associated with RA (overlap syndrome) linked to the development of ILD (interstitial lung disease) (systemic sclerosis, myositis, dermatomyositis, mixed connectivitis, systemic lupus erythematosus or other ANCA vasculitis, with the exception of secondary Gougerot-Sjögren's syndromes).
* Current or operated lung cancer
* Thoracic irradiation
* Thoracic transplant patients
* Previous invasive thoracic procedures
* Pathologies responsible for pleural thickening (silicosis, asbestosis, known pleural plaque, pleural sequelae of tuberculosis)
* Pregnant or breast-feeding women
* Patient under legal protection (guardianship, curatorship or safeguard of …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Determination sensitivity and specificity of thoracic ultrasound