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RecruitingNCT07174102Updated Sep 15, 2025

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

An observational study in Reumatoid Arthritis, Interstitial Lung Disease Due to Systemic Disease (Disorder) and Idiopathic Pulmonary Fibrosis (IPF), sponsored by Azienda Unita Sanitaria Locale di Piacenza. Recruiting at 5 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.

Sponsored by Azienda Unita Sanitaria Locale di Piacenza · Observational

From the registry’s dates

  • Started Jan 2025; still recruiting 1 year 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Ages
18 Years and older
Sex
All
01

Study 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. 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.

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.

02

Conditions studied

  • Reumatoid Arthritis
  • Interstitial Lung Disease Due to Systemic Disease (Disorder)
  • Idiopathic Pulmonary Fibrosis (IPF)
  • Connective Tissue Disease (CTD)

Keywords

  • rheumatoid arthritis
  • Interstitial lung disease
  • connective tissue disease
  • idiopathic pulmonary fibrosis
  • high resolution computed tomography
03

In context

Idiopathic Pulmonary Fibrosis

576 studies on the registry are indexed under Idiopathic Pulmonary Fibrosis; 123 are open to participants now.

This study's planned enrollment of 500 is above the median of 152 across 165 observational studies indexed under Idiopathic Pulmonary Fibrosis.

Browse Idiopathic Pulmonary Fibrosis studies →

Lead sponsor

Azienda Unita Sanitaria Locale di Piacenza is the lead sponsor of 15 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

RA patients or with idiopathic pulmonary fibrosis and other connective tissue diseases

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients able to give their
  • 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

Exclusion criteria

Exclusion criteria:

Patients younger than 18 and unable to give their .

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No

Groups and cohorts

  • Rheumatoid arthritis-interstitial lung disease group

    Patients with rheumatoid arthritis related interstitial lung disease undergoing to HRCT at any time of their clinical history

    Diagnostic Test: High resolution computed tomography

  • Idiopathic pulmonary fibrosis

    Patients with idiopathic pulmonary fibrosis underoging to HRCT at any time of their clincial history

    Diagnostic Test: High resolution computed tomography

  • Connective tissue disease - interstitial lung disease

    Patients with connective tissue diseases related interstitial lung disease undergoing to HRCT at any time of their clinical history

    Diagnostic Test: High resolution computed tomography

Interventions

  • Diagnostic testHigh resolution computed tomography

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

06

What researchers measure

Primary outcomes

  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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: At baseline and 24 months

Secondary outcomes

  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

    Time frame: 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

    Time frame: At baseline and 24 months

07

Study locations

4 of 5 sites recruiting
  • Institute of Rheumatology, Na Slupi 4
    Prague, Czechia
    Not yet recruiting
  • UOC Reumatologia, Arcipedale Sant'Anna
    Ferrara, Italy
    Recruiting
    • Andrea Lo Monaco · Contactlmnndr@unife.it · +039 0532 236314
    • Andrea Lo Monaco, MD · Principal investigator
  • SC Malattie Apparato Respiratorio, Azienda Policlinico di Modena
    Modena, Italy
    Recruiting
  • Local Health Unit ("Azienda Unità Sanitaria Locale", AUSL) of Piacenza
    Piacenza, 29121, Italy
    Recruiting
  • AUSL-IRCCS di Reggio Emilia
    Reggio Emilia, Italy
    Recruiting
    • Andreina Manfredi, MD · Contacta.manfredi@unimore.it · +390522 296684
    • Andreina prof. Manfredi · Principal investigator
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2025 (actual). Primary completion is estimated for Jan 2035, 120 months after the start.

Of 74 non-industry observational studies under Idiopathic Pulmonary Fibrosis, half reached primary completion within 63 months of starting (the median), counting those still running; a quarter within 29 and three quarters within 110. This study's planned 120 months is above that.

Counting every sponsor, half of 88 studies reached it within 54 months; a quarter within 29 and three quarters within 98.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 14, 2025
First posted
Sep 15, 2025
StartActual
Jan 8, 2025
Primary completionEst.
Jan 2035
CompletionEst.
Jan 2035
Last update
Sep 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07174102
Lead sponsor
Azienda Unita Sanitaria Locale di Piacenza
Collaborators
University of Parma
Responsible party
Sponsor
First posted
Sep 15, 2025
Start date
Jan 8, 2025
Primary completion
Jan 2035 (estimated)
Completion
Jan 2035 (estimated)
Last update
Sep 15, 2025

Study contacts

Marco Sebastiani, MD
Contact
m.sebastiani@ausl.pc.it
+39 0523302645
Francesca Cozzini, M.D.
Contact
f.cozzini@ausl.pc.it
+39 0523302645

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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