Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

Rheumatoid Arthritis Clinical Trial

— TRANSLATE2  

Official title:

Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04227535
• Other study ID #: K170801J
• Status: Active, not recruiting
• Start date: February 3, 2020
• Est. completion date: October 1, 2027

Study information

• Verified date: April 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 509
• Est. completion date: October 1, 2027
• Est. primary completion date: October 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Rheumatoid Arthritis

Locations

Country	Name	City	State
France	Bichat Hospital	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Bristol-Myers Squibb

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).	whole exome sequencing data	Baseline
Secondary	Identification of genetic factors implicated in RA-ILD using genome wide association study.	genome wide sequencing data	Baseline
Secondary	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
Secondary	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