dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

NCT06235645 | Recruiting

• 1 other identifier: DR230226 - EARLIER
• Study Type: observational
• Target: 280
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Interstitial Lung Disease; Thoracic Ultrasound; Lung Ultrasound

Keywords

Lung ultrasound; Rheumatoid Arthritis; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (1)

• Determination sensitivity and specificity of thoracic ultrasound

  The 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%.

  2 years

Secondary Outcomes (1)

• Percentage of each of the 3 ultrasound signs among pathological ultrasounds.

  2 years

Interventions

Lung ultrasound (LUS) DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients followed at CHU de Tours with a diagnosis of rheumatoid arthritis and with at least two risk factors for developing PR-PID

You may qualify if:

• 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 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Tours: lead

Study Sites (1)

university hospital Tours

Tours, 37000, France

RECRUITING

Related Publications (15)

• Gabbay E, Tarala R, Will R, Carroll G, Adler B, Cameron D, Lake FR. Interstitial lung disease in recent onset rheumatoid arthritis. Am J Respir Crit Care Med. 1997 Aug;156(2 Pt 1):528-35. doi: 10.1164/ajrccm.156.2.9609016.

  PMID: 9279235 RESULT

• Olson AL, Swigris JJ, Sprunger DB, Fischer A, Fernandez-Perez ER, Solomon J, Murphy J, Cohen M, Raghu G, Brown KK. Rheumatoid arthritis-interstitial lung disease-associated mortality. Am J Respir Crit Care Med. 2011 Feb 1;183(3):372-8. doi: 10.1164/rccm.201004-0622OC. Epub 2010 Sep 17.

  PMID: 20851924 RESULT

• Hyldgaard C, Hilberg O, Pedersen AB, Ulrichsen SP, Lokke A, Bendstrup E, Ellingsen T. A population-based cohort study of rheumatoid arthritis-associated interstitial lung disease: comorbidity and mortality. Ann Rheum Dis. 2017 Oct;76(10):1700-1706. doi: 10.1136/annrheumdis-2017-211138. Epub 2017 Jun 13.

  PMID: 28611082 RESULT

• Brown KK. Rheumatoid lung disease. Proc Am Thorac Soc. 2007 Aug 15;4(5):443-8. doi: 10.1513/pats.200703-045MS.

  PMID: 17684286 RESULT

• Bongartz T, Nannini C, Medina-Velasquez YF, Achenbach SJ, Crowson CS, Ryu JH, Vassallo R, Gabriel SE, Matteson EL. Incidence and mortality of interstitial lung disease in rheumatoid arthritis: a population-based study. Arthritis Rheum. 2010 Jun;62(6):1583-91. doi: 10.1002/art.27405.

  PMID: 20155830 RESULT

• Chen J, Shi Y, Wang X, Huang H, Ascherman D. Asymptomatic preclinical rheumatoid arthritis-associated interstitial lung disease. Clin Dev Immunol. 2013;2013:406927. doi: 10.1155/2013/406927. Epub 2013 Jul 31.

  PMID: 23983768 RESULT

• Dawson JK, Fewins HE, Desmond J, Lynch MP, Graham DR. Fibrosing alveolitis in patients with rheumatoid arthritis as assessed by high resolution computed tomography, chest radiography, and pulmonary function tests. Thorax. 2001 Aug;56(8):622-7. doi: 10.1136/thorax.56.8.622.

  PMID: 11462065 RESULT

• Matson S, Lee J, Eickelberg O. Two sides of the same coin? A review of the similarities and differences between idiopathic pulmonary fibrosis and rheumatoid arthritis-associated interstitial lung disease. Eur Respir J. 2021 May 13;57(5):2002533. doi: 10.1183/13993003.02533-2020. Print 2021 May.

  PMID: 33303554 RESULT

• Kawano-Dourado L, Doyle TJ, Bonfiglioli K, Sawamura MVY, Nakagawa RH, Arimura FE, Lee HJ, Rangel DAS, Bueno C, Carvalho CRR, Sabbag ML, Molina C, Rosas IO, Kairalla RA. Baseline Characteristics and Progression of a Spectrum of Interstitial Lung Abnormalities and Disease in Rheumatoid Arthritis. Chest. 2020 Oct;158(4):1546-1554. doi: 10.1016/j.chest.2020.04.061. Epub 2020 May 16.

  PMID: 32428513 RESULT

• Zamora-Legoff JA, Krause ML, Crowson CS, Ryu JH, Matteson EL. Progressive Decline of Lung Function in Rheumatoid Arthritis-Associated Interstitial Lung Disease. Arthritis Rheumatol. 2017 Mar;69(3):542-549. doi: 10.1002/art.39971.

  PMID: 27788297 RESULT

• Mohammadi A, Oshnoei S, Ghasemi-rad M. Comparison of a new, modified lung ultrasonography technique with high-resolution CT in the diagnosis of the alveolo-interstitial syndrome of systemic scleroderma. Med Ultrason. 2014 Mar;16(1):27-31. doi: 10.11152/mu.2014.2066.161.am1so2.

  PMID: 24567921 RESULT

• Manolescu D, Oancea C, Timar B, Traila D, Malita D, Birsasteanu F, Tudorache V. Ultrasound mapping of lung changes in idiopathic pulmonary fibrosis. Clin Respir J. 2020 Jan;14(1):54-63. doi: 10.1111/crj.13101. Epub 2019 Nov 14.

  PMID: 31675455 RESULT

• Pinal-Fernandez I, Pallisa-Nunez E, Selva-O'Callaghan A, Castella-Fierro E, Simeon-Aznar CP, Fonollosa-Pla V, Vilardell-Tarres M. Pleural irregularity, a new ultrasound sign for the study of interstitial lung disease in systemic sclerosis and antisynthetase syndrome. Clin Exp Rheumatol. 2015 Jul-Aug;33(4 Suppl 91):S136-41. Epub 2015 Aug 27.

  PMID: 26315813 RESULT

• Gutierrez M, Tardella M, Rodriguez L, Mendoza J, Clavijo-Cornejo D, Garcia A, Bertolazzi C. Ultrasound as a potential tool for the assessment of interstitial lung disease in rheumatic patients. Where are we now? Radiol Med. 2019 Oct;124(10):989-999. doi: 10.1007/s11547-019-01053-5. Epub 2019 Jul 2.

  PMID: 31267321 RESULT

• Cogliati C, Antivalle M, Torzillo D, Birocchi S, Norsa A, Bianco R, Costantino G, Ditto MC, Battellino M, Sarzi Puttini PC, Montano N. Standard and pocket-size lung ultrasound devices can detect interstitial lung disease in rheumatoid arthritis patients. Rheumatology (Oxford). 2014 Aug;53(8):1497-503. doi: 10.1093/rheumatology/keu033. Epub 2014 Mar 31.

  PMID: 24692573 RESULT

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Sylvie LEGUE

  University Hospital, Tours

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sylvie LEGUE

CONTACT

0247479835; s.legue@chu-tours.fr

Ariane MERLIN-DOMONT

CONTACT

x.ariane.md@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2024
• First Posted: February 1, 2024
• Study Start: November 18, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

FR (1)