Rheumatoid Arthritis-associated Interstitial Lung Disease Definition (RAID)

December 15, 2023 updated by: Denis Anna, Centre Hospitalier Universitaire de Liege

Multi-centric Prospective and Observational Study of Prevalence and Incidence of Interstitial Lung Diseases in Patients With Rheumatoid Arthritis

This is a prospective multicenter study in southern Belgium to determine the prevalence and incidence of interstitial lung disease in patients with rheumatoid arthritis (RA).

Study Overview

Status

Recruiting

Conditions

Detailed Description

This is a prospective multi-centric longitudinal study of the prevalence and incidence of pulmonary diseases in patients with RA.

During one year, patients with a RA diagnosis (according to the criteria of the American Society of Rheumatology) in the south of Belgium will be enrolled on a voluntary basis. If available, data including quality of life and symptoms questionnaires, medical examinations, 6-minute walk-tests, pulmonary function tests and chest CT will be collected during two years.

Furthermore, patients could be included (if available data) in two additional sub-cohorts:

  • "RAIDbio" sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers;
  • "RAIDomix" sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest).

Due to a non-specific and poor clinical expression at beginning, there is currently an under-diagnosis of rheumatoid arthritis associated-interstitial lung disease (RA-ILD) at an early stage and we assume that an annual pneumological follow-up, search of early biomarkers and a radiomic approach of RA patients will overcome this issue. This should lead to a better follow-up and management (including the use of anti-fibrotic therapies in the future) of these patients and ultimately to a decrease in morbidity and mortality.

Study Type

Observational

Enrollment (Estimated)

250

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with rheumatoid arthritis visiting their rheumatologist in South of Belgium and willing to participate

Description

Inclusion Criteria:

  • Diagnosis of rheumatoid arthritis according to the criteria of the American Society of Rheumatology
  • Age > 18 years
  • Willing to participate in the study and sign the informed consent form (ICF) of participants or their legal authorized representative
  • RAIDbio subcohort : available data for one of the following analysis of biomarkers: volatile organic compounds, induced sputum or blood markers
  • RAIDomix : available data for high resolution computed tomography of the chest

Exclusion Criteria: none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
General cohort
RAIDbio
Sub-cohort studying biomarkers: volatile organic compounds, induced sputum and blood biomarkers
RAIDomix
Sub-cohort studying radiomic patterns (based on high resolution computed tomography of the chest)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence and incidence
Time Frame: 2-5 years
To determine real-life prevalence and incidence of lung diseases in all patients with RA in South of Belgium
2-5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early diagnosis
Time Frame: 2-5 years
To diagnose RA-ILD at an earlier stage
2-5 years
Morbidty/mortality
Time Frame: 2-5 years
To decrease the morbidity and mortality associated with RA-ILD
2-5 years
Biomarkers
Time Frame: 2-5 years
To identify specific early biomarkers of RA-ILD
2-5 years
Radiomics
Time Frame: 2-5 years
To evaluate the prognosis value of radiomics approach in RA-ILD
2-5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Liege

Collaborators

Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 20, 2023

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

December 15, 2023

First Submitted That Met QC Criteria

December 15, 2023

First Posted (Actual)

December 28, 2023

Study Record Updates

Last Update Posted (Actual)

December 28, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022/52

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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