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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAzienda Unita Sanitaria Locale di Piacenza

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

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

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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

Treatment groups

500 Participants
are divided into 3 treatment groups
Group A: Rheumatoid arthritis-interstitial lung disease group1 intervention
Group B: Idiopathic pulmonary fibrosis1 intervention
Group C: Connective tissue disease - interstitial lung disease1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

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