Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

Active, not recruiting

• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

• Registration Number: NCT04227535
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2019-07-15
• Study First Submitted QC: 2020-01-10
• Study First Posted: 2020-01-13
• Study Start: 2020-02-03
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-27
• Last Update Posted: 2023-04-28
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 509

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).	Baseline	whole exome sequencing data

Secondary Outcome Measures

Name	Time	Method
Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.	Every year during 5 years	Decline of pulmonary functional tests (PFT) as well as changes in High-Resolution Computed-Tomography chest scan scores
Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.	Every year during 5 years	Influence of treatment (DMARDs and biologics) over RA-ILD course estimated annually given the cumulated dosage received.
Identification of genetic factors implicated in RA-ILD using genome wide association study.	Baseline	genome wide sequencing data

Trial Locations

Locations (1)

Bichat Hospital; 🇫🇷 Paris, France