Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2 (TRANSLATE2)

Assistance Publique - Hôpitaux de Paris

Status: Active, not recruiting

Conditions: Interstitial Lung Disease; Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04227535

K170801J

Details and patient eligibility

About

The overall goal of this study is to identify risk and prognosis factors of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA).

Full description

This is not an interventional study. This is a study designed to recruit individuals affected by RA and investigate associated ILD to better understand the clinical phenotypes and genetic/molecular endotypes of RAILD, including the prognosis of the disease.

Enrollment: 509 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

SELECTION OF CASES :

Inclusion Criteria:

• Age ≥18 years
• RA diagnosis according to ACR (classification of rheumatoid arthritis) 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist
• ILD diagnosis based on typical High-Resolution Computed-Tomography (HCRT) patterns and pulmonary function tests (PFT), validated by a senior pulmonologist

Exclusion Criteria:

• Lack of signed informed consent

SELECTION OF CONTROLS:

Inclusion Criteria:

• Age ≥18 years
• RA diagnosis according to ACR 1987 and/or ACR/EULAR 2010 criteria, validated by a senior rheumatologist

Exclusion Criteria:

• Lack of signed informed consent

Trial design

509 participants in 2 patient groups

Rheumatoid arthritis - Interstitial lung disease patients

Description:

Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum

Rheumatoid arthritis - no Interstitial lung disease patients

Description:

Assessment are as follows : 1. Clinical: Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) 2. Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance 3. Radiologic: chest HRCT scan 4. Genetic: DNA, mRNA 5. Biologic: serum