Rheumatoid Arthritis-associated Interstitial Lung Disease Definition

Recruiting

• Conditions: Rheumatoid Arthritis-Associated Interstitial Lung Disease

• Registration Number: NCT06184893
• Lead Sponsor: Centre Hospitalier Universitaire de Liege

Brief Summary

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

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.

Study Timeline

• Study Start: 2023-11-20
• Status Verified: 2023-12
• Study First Submitted: 2023-12-15
• Study First Submitted QC: 2023-12-15
• Last Update Submitted: 2023-12-15
• Study First Posted: 2023-12-28
• Last Update Posted: 2023-12-28
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence and incidence	2-5 years	To determine real-life prevalence and incidence of lung diseases in all patients with RA in South of Belgium

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Centre Hospitalier Universitaire de Liege; 🇧🇪 Liege, Belgium