Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04227535

Acronym

TRANSLATE2

Enrollment

509

Registered

2020-01-13

Start date

2020-02-03

Completion date

2027-10-01

Last updated

2023-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Interstitial Lung Disease, Rheumatoid Arthritis

Keywords

Rheumatoid Arthritis, Interstitial lung disease

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Identification of genetic factors implicated in RA-ILD using genome wide association study.	Baseline	genome wide sequencing data
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.

Countries

France

Outcome results