Clinical trial NCT06184893: Rheumatoid Arthritis-associated Interstitial Lung Disease Definition
Official title: Multi-centric Prospective and Observational Study of Prevalence and Incidence of Interstitial Lung Diseases in Patients With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rheumatoid Arthritis-Associated Interstitial Lung Disease
Keywords: rheumatoid arthritis
rheumatoid arthritis-associated interstitial lung disease
interstitial lung disease
Lead sponsor: Centre Hospitalier Universitaire de Liege
Sponsor class: OTHER
Collaborators: name: Boehringer Ingelheim
First posted: 2023-12-28
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with rheumatoid arthritis visiting their rheumatologist in South of Belgium and willing to participate

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.

Eligibility criteria: 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

Primary outcomes:
measure: Prevalence and incidence
timeFrame: 2-5 years
Secondary outcomes:
measure: Early diagnosis
timeFrame: 2-5 years
measure: Morbidty/mortality
timeFrame: 2-5 years
measure: Biomarkers
timeFrame: 2-5 years
measure: Radiomics
timeFrame: 2-5 years
Other outcomes:
Locations:
city: Liege
country: Belgium
facility: Centre Hospitalier Universitaire de Liege
Study officials:
References: