NCT06184893

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 20, 2023

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

December 15, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 28, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
Last Updated

December 28, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

December 15, 2023

Last Update Submit

December 15, 2023

Conditions

Rheumatoid Arthritis-Associated Interstitial Lung Disease

Keywords

rheumatoid arthritisrheumatoid arthritis-associated interstitial lung diseaseinterstitial lung disease

Outcome Measures

Primary Outcomes (1)

  • Prevalence and incidence

    To determine real-life prevalence and incidence of lung diseases in all patients with RA in South of Belgium

    2-5 years

Secondary Outcomes (4)

  • Early diagnosis

    2-5 years

  • Morbidty/mortality

    2-5 years

  • Biomarkers

    2-5 years

  • Radiomics

    2-5 years

Study Arms (3)

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)

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire de Liege

Liège, 4000, Belgium

RECRUITING

MeSH Terms

Conditions

Arthritis, RheumatoidLung Diseases, Interstitial

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System DiseasesLung DiseasesRespiratory Tract Diseases

Central Study Contacts

Julien Guiot, PhD

CONTACT

00324/323 7881j.guiot@chuliege.be

Anna Denis, MD

CONTACT

00324/323 7881anna.denis@chulige.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical doctor

Study Record Dates

First Submitted

December 15, 2023

First Posted

December 28, 2023

Study Start

November 20, 2023

Primary Completion

October 1, 2025

Study Completion

October 1, 2025

Last Updated

December 28, 2023

Record last verified: 2023-12

Locations

BE(1)