Skip to content

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06235645
Acronym
EARLIER
Enrollment
280
Registered
2024-02-01
Start date
2024-11-18
Completion date
2027-03-01
Last updated
2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease, Lung Ultrasound, Rheumatoid Arthritis, Thoracic Ultrasound

Keywords

Lung ultrasound, Rheumatoid Arthritis, Interstitial Lung Disease

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.

Detailed description

Patients with RA and who have risk factors for RA-ILD are regularly reassessed in a rheumatology day hospital. As part of their routine follow-up, and given the absence of recommendations on screening for RA-ILD in this population, chest CT and PFT (pulmonary function tests) are regularly performed at the request of the rheumatologist. Therefore, all patients meeting the inclusion criteria and having undergone chest CT and PFT in the 6 months preceding or following their rheumatology reassessment will be offered participation in the study. Participation in the study does not alter the patient's usual follow-up. Objective of the study: evaluate the sensitivity and specificity of thoracic ultrasound compare to the chest CT in patients with risk factors of developing RA-ILD. Design: This is a non-interventional, prospective, single-center, multidisciplinary study.

Interventions

DIAGNOSTIC_TESTLung ultrasound (LUS)

If included, an LUS will be performed by an experienced operator, blinded to the results of the chest CT and PFT. A linear probe (4 to 12 MHz) will be used. The patient will be installed́ in a semi-seated position with the homolateral arm above the head for the anterior and axillary evaluation then, depending on his comfort, in a seated position or in right then left lateral decubitus, arms alongside the body, for the posterior evaluation. It will be practiced by experienced operators (pneumologist) and according to a validated protocol allowing the exploration of 14 intercostal spaces. LUT will be timed, recorded and anonymized. The operator will note the 3 ultrasound signs (total number of B lines, pleural line thickening and percentage of pleural line irregularity), their location and severity. The radiologist, on his part, will evaluate the patient's chest CT (gold standard), blinded to the results of the LUS, to make or not the diagnosis of RA-ILD.

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Determination sensitivity and specificity of thoracic ultrasound2 yearsThe primary outcome is to determine the sensitivity and specificity of thoracic ultrasound defined as pathological by a total number of B lines ≥ 9 and/or pleural line thickening ≥ 3mm and/or a percentage of pleural line irregularity ≥ 24%.

Secondary

MeasureTime frameDescription
Percentage of each of the 3 ultrasound signs among pathological ultrasounds.2 yearsThe secondary outcome is the percentage of each of the 3 ultrasound signs among pathological ultrasounds.

Countries

France

Contacts

CONTACTSylvie LEGUE
s.legue@chu-tours.fr0247479835
CONTACTAriane MERLIN-DOMONT
x.ariane.md@gmail.com
PRINCIPAL_INVESTIGATORSylvie LEGUE

University Hospital, Tours

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026