Developing a Screening Tool for Interstitial Lung Disease in People With Rheumatoid Arthritis Using Risk Factors

Active, not recruiting

• Conditions: Arthritis, Rheumatoid; Lung Diseases, Interstitial

• Registration Number: NCT05855109
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The overall aim of the study is to develop and validate a Rheumatoid Arthritis-Interstitial Lung Disease (RA-ILD) clinical prediction model (screening tool) based on risk factors to guide screening for ILD in patients with RA using High Resolution Computed Tomography (HRCT).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-05-03
• Study First Submitted QC: 2023-05-03
• Study First Posted: 2023-05-11
• Study Start: 2023-11-27
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-04
• Primary Completion: 2025-07-10
• Study Completion: 2025-07-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1203

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probability score based on multi-variable diagnostic model that incorporates risk factors commonly available in clinical practice for RA-ILD screening	up to 1 year	The endpoint of the model will be to recommend screening HRCT scan based on risk factors.
Prevalence of RA-ILD and radiological features of RA-ILD on HRCT	up to 1 year

Secondary Outcome Measures

Name	Time	Method
Disease characteristics of patients with and without ILD symptoms: Duration of Rheumatoid Arthritis	up to 1 year
Disease characteristics of patients with and without ILD symptoms: Diffusing Capacity for Carbon Monoxide	up to 1 year
Disease characteristics of patients with and without ILD symptoms: Disease Activity Score (DAS) 28	up to 1 year	The DAS28 score ranges from 0 to 9.4 with higher values reflecting a higher disease activity.
Disease characteristics of patients with and without ILD symptoms: Forced Vital Capacity	up to 1 year
Diagnostic performance of clinical prediction model in asymptomatic and symptomatic sub-populations	up to 1 year	The overall apparent performance of the model will primarily be assessed using the Brier Score. Discrimination will be assessed using the Area Under the Curve (AUC) (c-statistic) and callibration will be analysed with a calibration plot.
Correlation of abnormal findings on pulmonary function testing (PFT) and auscultation relevant to ILD to HRCT findings	up to 1 year
Demographics of patients with and without ILD symptoms	up to 1 year	Age, sex, race (Baseline characteristics)

Trial Locations

Locations (28)

Hospital Universitario 12 de Octubre; 🇪🇸 Madrid, Spain

Hospital General Universitario De Valencia; 🇪🇸 Valencia, Spain

Hospital Do Meixoeiro; 🇪🇸 Vigo, Spain

Stanford University School of Medicine; 🇺🇸 Palo Alto, California, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Harvard Medical School - Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Michigan Health System; 🇺🇸 Ann Arbor, Michigan, United States

University of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States

Clinique de l'infirmerie Protestante; 🇫🇷 Caluire-et-Cuire, France

Assistance Publique - Hopitaux de Paris (AP-HP) - Hopital Cochin; 🇫🇷 Paris, France

Hopital Bichat, APHP; 🇫🇷 Paris, France

Centre Hospitalier Universitaire (CHU) de Saint-Etienne - Hopital Nord; 🇫🇷 Saint Priest en Jarez, France

Rheumazentrum Prof. Dr. med Gunther Neeck; 🇩🇪 Bad Doberan, Germany

Charite - Universitaetsmedizin Berlin - Campus Charite Mitte (CCM); 🇩🇪 Berlin, Germany

Dr. Jochen Walter MD, Office Of; 🇩🇪 Rendsburg, Germany

Di.M.I. Irccs A.O.S.Martino (U.O.Clinica Reumatological); 🇮🇹 Genova, Italy

Fondazione Irccs Ca' Granda Ospedale Maggioe Policlinico Di Milano; 🇮🇹 Milan, Italy

Azienda Ospedaliero-Universitaria Policlinico di Modena; 🇮🇹 Modena, Italy

AOU di Padova; 🇮🇹 Padova, Italy

Fondazione Policlinico Universitario - Agostino Gemelli, Universita Cattolica del Sacro Cuore; 🇮🇹 Roma, Italy

Azienda Ospedaliera Universitaria Integrata di Verona - Ospedale Borgo Roma; 🇮🇹 Verona, Italy

Hospital Clinic de Barcelona (Hospital Clinic i Provincial); 🇪🇸 Barcelona, Spain

Hospital Universitario Reina Sofia; 🇪🇸 Cordoba, Spain

Hospital Universitario Ramon y Cajal; 🇪🇸 Madrid, Spain

Nottingham University Hospitals NHS Trust - Nottingham City Hospital; 🇬🇧 Nottingham, United Kingdom

Southampton General Hospital - University Hospital Southampton NHS Foundation Trust; 🇬🇧 Southampton, United Kingdom

Leeds University; 🇬🇧 West Yorkshire, United Kingdom

Southend University Hospital - Mid Essex Hospital Services NHS Trust; 🇬🇧 Westcliff-On-Sea, United Kingdom