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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

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 Type: Observational
• Enrollment (Actual): 509

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Bichat Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

The population of interest are individuals affected by RA with ILD (RA-ILD). Individuals affected with RA and without ILD (RA-noILD) will be included as a control population. The ILD status being systematically assessed by HRCT chest scan.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Rheumatoid arthritis - Interstitial lung disease patients; Assessment are as follows : 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); Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance; Radiologic: chest HRCT scan; Genetic: DNA, mRNA; Biologic: serum
Rheumatoid arthritis - no Interstitial lung disease patients; Assessment are as follows : 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); Physiologic:Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance; Radiologic: chest HRCT scan; Genetic: DNA, mRNA; Biologic: serum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).	whole exome sequencing data	Baseline

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Philippe DIEUDE, MD, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (Actual): February 3, 2020
• Primary Completion (Anticipated): October 1, 2027
• Study Completion (Anticipated): October 1, 2027

Study Registration Dates

• First Submitted: July 15, 2019
• First Submitted That Met QC Criteria: January 10, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 27, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; Interstitial lung disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: K170801J

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No