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Rheumatoid ArthritisEARLIERNCT06235645

dEtection of rheumAtoid aRthritis - Interstitial Lung dIseasE by Thoracic ultRasound

An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by University Hospital, Tours at 1 site in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Lung ultrasound (LUS)
How many people
280 participants
Where
1 siteFrance
Study dates
18 Nov 2024to Mar 2027
Phase
Observational
Are there results?
Not yet: the study is under way

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

Who may be able to join

  • 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
Show all 9Show fewer
  • 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)

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Ariane MERLIN-DOMONT contact

x.ariane.md@gmail.com

France1 site, 1 recruiting
  • university hospital Tours

    Tours, 37000

    Sylvie LEGUE, 247479835 ext. +33, s.legue@chu-tours.fr

    Ariane MERLIN-DOMONT, x.ariane.md@gmail.com

    Recruiting

Other trials in France

About this study

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.

Read more

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.

Read the 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.

Being tested
Lung ultrasound (LUS)
Keywords
Lung ultrasound, Rheumatoid Arthritis, Interstitial Lung Disease
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.

  • 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: 2 years

Secondary outcomes (1)
  1. Percentage of each of the 3 ultrasound signs among pathological ultrasounds.

    The secondary outcome is the percentage of each of the 3 ultrasound signs among pathological ultrasounds.

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2024
  2. Study start18 Nov 2024
  3. Primary completionNov 2026 (estimated)
  4. Study completionMar 2027 (estimated)

Resources

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
Case only
Time perspective
Prospective
Enrolment
280 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06235645
Sponsor's protocol ID
DR230226 - EARLIER
Acronym
EARLIER
Status last verified
Apr 2026
First submitted
23 Jan 2024
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 9279235
  • 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.

    PubMed 20851924
  • 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.

    PubMed 28611082
  • Brown KK. Rheumatoid lung disease. Proc Am Thorac Soc. 2007 Aug 15;4(5):443-8. doi: 10.1513/pats.200703-045MS.

    PubMed 17684286
  • 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.

    PubMed 20155830
  • 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.

    PubMed 23983768
  • 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.

    PubMed 11462065
  • 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.

    PubMed 33303554
  • 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.

    PubMed 32428513
  • 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.

    PubMed 27788297
  • 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.

    PubMed 24567921
  • 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.

    PubMed 31675455
  • 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.

    PubMed 26315813
  • 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.

    PubMed 31267321
  • 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.

    PubMed 24692573

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by University Hospital, Tours at 1 site in France.

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 9 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 30 Apr 2026. 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 France. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Sylvie LEGUE (0247479835 ext. +33, s.legue@chu-tours.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Determination sensitivity and specificity of thoracic ultrasound (time frame: 2 years). 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 NCT06235645, which also lists 15 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 30 Apr 2026.

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