NCT06235645 dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound
| NCT ID | NCT06235645 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Tours |
| Condition | Rheumatoid Arthritis |
| Study Type | OBSERVATIONAL |
| Enrollment | 280 participants |
| Start Date | 2024-11-18 |
| Primary Completion | 2026-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 280 participants in total. It began in 2024-11-18 with a primary completion date of 2026-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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 justice) * Patient who has objected to data processing * Parenchymal infection current or less than one month old prior to LUS examination * Liquid or gaseous pleural effusion
Contact & Investigator
Sylvie LEGUE
PRINCIPAL INVESTIGATOR
University Hospital, Tours
Frequently Asked Questions
Who can join the NCT06235645 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Rheumatoid Arthritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06235645 currently recruiting?
Yes, NCT06235645 is actively recruiting participants. Contact the research team at s.legue@chu-tours.fr for enrollment information.
Where is the NCT06235645 trial being conducted?
This trial is being conducted at Tours, France.
Who is sponsoring the NCT06235645 clinical trial?
NCT06235645 is sponsored by University Hospital, Tours. The principal investigator is Sylvie LEGUE at University Hospital, Tours. The trial plans to enroll 280 participants.
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