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

NCT07174102 | Recruiting

• 1 other identifier: ARD-ILD-HRCT
• Study Type: observational
• Target: 500
• Locations: 2 countries
• Sites: 5

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• 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

  At baseline and 24 months

• Prevalence of honeycombing

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

  At baseline and 24 months

• 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

  At baseline and 24 months

• 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

  At baseline and 24 months

Secondary Outcomes (2)

• Prevalence of exuberant honeycombing

  At baseline and 24 months

• Prevalence of straight sign

  At baseline and 24 months

Study Arms (3)

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

High resolution computed tomography DIAGNOSTIC_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

Connective tissue disease - interstitial lung disease; Idiopathic pulmonary fibrosis; Rheumatoid arthritis-interstitial lung disease group

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

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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Azienda Unita Sanitaria Locale di Piacenza: lead
• University of Parma: collaborator

Study Sites (5)

Institute of Rheumatology, Na Slupi 4

Prague, Czechia

NOT YET RECRUITING

UOC Reumatologia, Arcipedale Sant'Anna

Ferrara, Italy

RECRUITING

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

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Connective Tissue Diseases; Arthritis, Rheumatoid; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Marco Sebastiani, MD

CONTACT

+39 0523302645; m.sebastiani@ausl.pc.it

Francesca Cozzini, M.D.

CONTACT

+39 0523302645; f.cozzini@ausl.pc.it

Study Design

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

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: September 15, 2025
• Study Start: January 8, 2025
• Primary Completion (Estimated): January 1, 2035
• Study Completion (Estimated): January 1, 2035
• Last Updated: September 15, 2025

Record last verified: 2025-09

Locations

CZ (1); IT (4)