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OpenTrials
Active, Not Recruiting

NCT Number: NCT04227535

Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Interstitial Lung Disease Joint Diseases Lung Diseases Lung Diseases, Interstitial Musculoskeletal Diseases Respiratory Tract Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Bichat Hospital

Paris, 75018, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Identification of genetic factors implicated in RA-ILD using whole exome sequencing (WES).

    Time frame: Baseline

    whole exome sequencing data

Secondary outcomes

  1. Identification of genetic factors implicated in RA-ILD using genome wide association study.

    Time frame: Baseline

    genome wide sequencing data

  2. Describe RA-ILD natural history by a 5 years annual follow up of RA-ILD patients.

    Time frame: Every year during 5 years

    Decline of pulmonary functional tests (PFT) as well as changes in High-Resolution Computed-Tomography chest scan scores

  3. Description of the effect of disease modifying Anti Rheumatic Drugs (DMARDs) on ILD course and mortality.

    Time frame: Every year during 5 years

    Influence of treatment (DMARDs and biologics) over RA-ILD course estimated annually given the cumulated dosage received.

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Collaborators

  • Bristol-Myers Squibb

Registry information

Acronym: TRANSLATE2

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Jan 13, 2020
Registry last updated
Apr 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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