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Reumatoid ArthritisNCT07174102

Radiologic Features of Rheumatoid Arthritis Interstitial Lung Disease at Chest High Resolution Computed Tomography

An observational study of Reumatoid Arthritis and Interstitial Lung Disease Due to Systemic Disease (Disorder), run by Azienda Unita Sanitaria Locale di Piacenza at 5 sites in 2 countries.

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

Lung involvement is one of the most frequent extra articular involvements of rheumatoid arthritis (RA). RA related lung involvement can affect parenchyma, airway, vascular tree and serosa. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
High resolution computed tomography
How many people
500 participants
Where
5 sitesin 2 countries
Study dates
8 Jan 2025to Jan 2035
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: RA patients or with idiopathic pulmonary fibrosis and other connective tissue diseases

Who may be able to join

  • patients able to give their informed consent
  • at least aged 18 years
  • patients undergoing High-Resolution Computed Tomography (HRCT) for clinical needs at any point in their medical history
  • patients with a diagnosis of rheumatoid arthritis, idiopathic pulmonary fibrosis or connective tissue disease

Who cannot join

  • Patients younger than 18 and unable to give their informed consent.

Trial locations and contacts

5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Marco Sebastiani, MD contact

+39 0523302645

m.sebastiani@ausl.pc.it

Francesca Cozzini, M.D. contact

+39 0523302645

f.cozzini@ausl.pc.it

5 sites in 2 countries

Italy4 sites, 4 recruiting
  • UOC Reumatologia, Arcipedale Sant'Anna

    Ferrara

    Andrea Lo Monaco, +039 0532 236314, lmnndr@unife.it

    Andrea Lo Monaco, MD

    Recruiting
  • SC Malattie Apparato Respiratorio, Azienda Policlinico di Modena

    Modena

    Stefania Cerri, +090594222111, stefania.cerri@unimore.it

    Stefania Cerri, prof

    Recruiting
  • Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza

    Piacenza, 29121

    Marco Sebastiani, MD, marco.sebastiani@unipr.it

    Francesca Cozzini, MD, f.cozzini@ausl.pc.it

    Recruiting
  • AUSL-IRCCS di Reggio Emilia

    Reggio Emilia

    Andreina Manfredi, MD, +390522 296684, a.manfredi@unimore.it

    Andreina prof. Manfredi

    Recruiting

Other trials in Italy

Czechia1 site, 1 recruiting
  • Institute of Rheumatology, Na Slupi 4

    Prague

    Jiří Vencovský, +420 224 914 469, vencovsky@revma.cz

    Not yet recruiting

Other trials in Czechia

About this study

Official title: Radiologic Features of Patients With Rheumatoid Arthritis Related Interstitial Lung Disease at Chest High Resolution Computed Tomography

Lung involvement is one of the most frequent extra articular involvements of rheumatoid arthritis (RA). RA related lung involvement can affect parenchyma, airway, vascular tree and serosa. Among all possible manifestations of lung disease, interstitial lung disease is the most severe being able to compromise quality of life and survival and involves about 20% of patients with rheumatoid arthritis (RA). However, chest high resolution computed tomography (HRCT) features of RA, with or without interstitial lung involvement, have not been clearly defined. Such features have been mostly investigated on small populations of RA patients, often including patients with connective tissue diseases (CTDs), namely systemic sclerosis, mixed connective tissue disease, idiopathic inflammatory myopathies, making difficult to discriminate possible specific features of RA interstitial lung disease (ILD).

The aims of this observational longitudinal study are to investigate: i) chest HRCT features of RA (frequency of radiologic HRCT patterns, fibrosis, nodules, bronchiectasis, etc.), associated or not to ILD; ii) possible associations between chest HRCT features and demographic, clinical and serologic characteristics of RA; iii) specific chest HRCT features of RA ILD, compared to idiopathic pulmonary fibrosis (IPF) and CTD ILD (i.e., primary Sjogren syndrome, idiopathic inflammatory myopathies, etc), according to the Centres availability.

Read more

Consecutive, unselected, DICOM files of chest HRCT of adult RA patients (regardless a previous diagnosis of ILD) will be evaluated by an expert thoracic radiologist blinded to patients' clinical history.

HRCT patterns, presence of fibrosis and other lung abnormalities (cysts, nodules, pleural effusion, etc) will be recorded. In patients with RA ILD possible associations with demographic and clinical disease features will be also analysed (such as sex, disease duration, disease duration at ILD diagnosis, presence of ACPA, rheumatoid factor, ANA), inclusion of previous therapies.

After 2 years, new HRCT and lung function tests will be collected for each enrolled patients when available, to evaluate possible changes of lung involvement over time.

Read the detailed description

Lung involvement is one of the most frequent extra-articular involvements of rheumatoid arthritis (RA). RA-related lung involvement can affect parenchyma, airway, vascular tree and serosa. Among all possible manifestations of lung disease, interstitial lung disease is the most severe being able to compromise quality of life and survival and involves about 20% of patients with rheumatoid arthritis (RA).

However, chest high resolution computed tomography (HRCT) features of RA, with or without interstitial lung involvement, have not been clearly defined. Such features have been mostly investigated on small populations of RA patients, often including patients with connective tissue diseases (CTDs), namely systemic sclerosis, mixed connective tissue disease, idiopathic inflammatory myopathies, making difficult to discriminate possible specific features of RA-interstitial lung disease (ILD).

This observational longitudinal study aims to investigate:

  • Chest HRCT features of RA-ILD (frequency of radiologic HRCT patterns, fibrosis, nodules, bronchiectasis, etc). Possible findings specific for RA independently from ILD will be also analysed.
  • Possible associations between chest HRCT features and demographic, clinical and serologic characteristics of RA.
  • Specific chest HRCT features of RA-ILD, compared to idiopathic pulmonary fibrosis (IPF) and CTD-ILD (i.e., primary Sjogren syndrome, idiopathic inflammatory myopathies, etc) according to the Centres availability.

All consecutive RA patients, older than 18 and able to understand the aims of the study and undergoing HRCT for clinical needs will be enrolled in the study.

Patients with idiopathic pulmonary fibrosis and other CTDs undergoing to HRCT will be enrolled as control groups Patients younger than 18 and unable to give their informed consent will be excluded from the study

Consecutive, unselected, DICOM files of chest HRCT of RA patients (regardless a previous diagnosis of ILD) will be evaluated by an expert thoracic radiologist blinded to patients' clinical history. The DICOM images will be anonymized, coded and sent to the coordinating centre by transfer to a dedicated server whose access will be protected by a password. If deemed clinically necessary, patients will also be evaluated by a pulmonologist expert in the treatment of fibrosing lung diseases.

HRCT patterns, presence of fibrosis and other lung abnormalities (cysts, nodules, pleural effusion, etc) will be recorded. In patients with RA-ILD possible associations with demographic and clinical disease features will be also analysed (such as sex, disease duration, disease duration at ILD diagnosis, presence of ACPA, rheumatoid factor, ANA), inclusion of previous therapies.

RA diagnosis must be performed according to 2010 EULAR/ACR classification criteria, overlap syndrome are excluded from the study.

To evaluate specific HRCT features of RA-ILD, consecutive, unselected DICOM files of chest HRCT of patients with IPF and CTD-ILD (i.e., primary Sjogren syndrome, idiopathic inflammatory myopathies or other, according to the Centres availability) will be also evaluated by an expert thoracic radiologist blinded to patients' clinical history.

After 2 years, new HRCT and lung function tests will be collected for each enrolled patients when available, to evaluate possible changes of lung involvement over time.

Being tested
High resolution computed tomography
Keywords
rheumatoid arthritis, Interstitial lung disease, connective tissue disease, idiopathic pulmonary fibrosis, high resolution computed tomography
Medical subject headings
Idiopathic Pulmonary Fibrosis, Connective Tissue Diseases, Arthritis, Rheumatoid, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • High resolution computed tomographyDiagnostic test

    High resolution computed tomography perfomed in patients with rheumatoid arthritis and connective tissue diseases with or without interstitial lung disease, and idiopathic pulmonary fibrosis

Study groups in NCT07174102
Study groupRoleWhat they receive
Rheumatoid arthritis-interstitial lung disease groupPatients with rheumatoid arthritis related interstitial lung disease undergoing to HRCT at any time of their clinical history
Receives: Diagnostic Test: High resolution computed tomography
Idiopathic pulmonary fibrosisPatients with idiopathic pulmonary fibrosis underoging to HRCT at any time of their clincial history
Receives: Diagnostic Test: High resolution computed tomography
Connective tissue disease - interstitial lung diseasePatients with connective tissue diseases related interstitial lung disease undergoing to HRCT at any time of their clinical history
Receives: Diagnostic Test: High resolution computed tomography

What is being measured

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

  1. Prevalence of radiologic interstitial lung disease patterns

    Prevalence of radiologic interstitial lung disease patterns in patients with rheumatoid arthritis related interstitial lung disease compared with other rheumatic diseases

    Measured: At baseline and 24 months

  2. Prevalence of honeycombing

    Prevalence of honeycombing in rheumatoid arthritis patients related interstitial lung disease compared to other rheumatic diseases at the enrollment

    Measured: At baseline and 24 months

  3. Prevalence of anterior honeycombing

    Prevalence of anterior honeycombing in patients with rheumatoid related interstitial lung disease compared with other rheumatic diseases and idiopatic pulmonary fibrosis

    Measured: At baseline and 24 months

  4. Progression of fibrotic features

    New HRCT will be collected for each enrolled patients when available, to evaluate possible changes of fibrotic features described at baseline

    Measured: At baseline and 24 months

Secondary outcomes (2)
  1. Prevalence of exuberant honeycombing

    Prevalence of exuberant honeycombing in patients with rheumatoid related interstitial lung disease compared with other rheumatic diseases and idiopatic pulmonary fibrosis

    Measured: At baseline and 24 months

  2. Prevalence of straight sign

    Prevalence of exuberant honeycombing in patients with rheumatoid related interstitial lung disease compared with other rheumatic diseases and idiopatic pulmonary fibrosis

    Measured: At baseline and 24 months

Timeline

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

  1. First posted15 Sep 2025
  2. Study start8 Jan 2025
  3. Primary completionJan 2035 (estimated)
  4. Study completionJan 2035 (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
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07174102
Sponsor's protocol ID
ARD-ILD-HRCT
Status last verified
Sep 2025
First submitted
14 Aug 2025
Last updated
15 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Reumatoid Arthritis and Interstitial Lung Disease Due to Systemic Disease (Disorder), run by Azienda Unita Sanitaria Locale di Piacenza at 5 sites in 2 countries.

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 4 inclusion and 1 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 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Italy, Czechia. 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 Marco Sebastiani, MD (+39 0523302645, m.sebastiani@ausl.pc.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of radiologic interstitial lung disease patterns (time frame: At baseline and 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
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 15 Sep 2025.

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