Rheumatoid Arthritis-associated Interstitial Lung Disease Definition

Study Overview
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Brief Summary
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This is a prospective multicenter study in southern Belgium to determine the prevalence and incidence of interstitial lung disease in patients with rheumatoid arthritis (RA).

Detailed Description
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This is a prospective multi-centric longitudinal study of the prevalence and incidence of pulmonary diseases in patients with RA. During one year, patients with a RA diagnosis (according to the criteria of the American Society of Rheumatology) in the south of Belgium will be enrolled on a voluntary basis. If available, data including quality of life and symptoms questionnaires, medical examinations, 6-minute walk-tests, pulmonary function tests and chest CT will be collected during two years. Furthermore, patients could be included (if available data) in two additional sub-cohorts: RAIDbio sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers; RAIDomix sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest). Due to a non-specific and poor clinical expression at beginning, there is currently an under-diagnosis of rheumatoid arthritis associated-interstitial lung disease (RA-ILD) at an early stage and we assume that an annual pneumological follow-up, search of early biomarkers and a radiomic approach of RA patients will overcome this issue. This should lead to a better follow-up and management (including the use of anti-fibrotic therapies in the future) of these patients and ultimately to a decrease in morbidity and mortality.

Official Title
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Multi-centric Prospective and Observational Study of Prevalence and Incidence of Interstitial Lung Diseases in Patients With Rheumatoid Arthritis

Conditions
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Rheumatoid Arthritis-Associated Interstitial Lung Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of rheumatoid arthritis according to the criteria of the American Society of Rheumatology Age > 18 years Willing to participate in the study and sign the informed consent form (ICF) of participants or their legal authorized representative RAIDbio subcohort : available data for one of the following analysis of biomarkers: volatile organic compounds, induced sputum or blood markers RAIDomix : available data for high resolution computed tomography of the chest Exclusion Criteria: none

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| General cohort<br> | |
| RAIDbio<br>Sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers | |
| RAIDomix<br>Sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence and incidence | To determine real-life prevalence and incidence of lung diseases in all patients with RA in South of Belgium | 2-5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early diagnosis | To diagnose RA-ILD at an earlier stage | 2-5 years | 
| Morbidty/mortality | To decrease the morbidity and mortality associated with RA-ILD | 2-5 years | 
| Biomarkers | To identify specific early biomarkers of RA-ILD | 2-5 years | 
| Radiomics | To evaluate the prognosis value of radiomics approach in RA-ILD | 2-5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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rheumatoid arthritis, rheumatoid arthritis-associated interstitial lung disease, interstitial lung disease