NCT06965322

Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis

Prospective Observational Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 800 (estimated)
• Sponsor: Medical University Innsbruck · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of the study is to develop a standardized, risk-adapted screening protocol for detecting pleuropulmonary manifestations in patients with rheumatoid arthritis. To assess the risk of these manifestations, a comprehensive range of functional and clinical evaluations will be performed and correlated with structural lung assessments using computed tomography (CT).

Detailed description

The objective of the study is the establishment of a standardized risk-adapted screening protocol for detecting pleuropulmonary manifestations in patients with rheumatoid arthritis. To determine the risk of pleuropulmonary manifestation in RA, clinical (pulmonological and rheumatological specialist examination including standardized disease activity and symptom scores), laboratory (e.g. RF, ACPA, CRP, CEA), lung function (incl. body plethysmography, TLCO, FeNO, SMWT), sonographic (thoracic ultrasound, joint ultrasound), and demographic (e.g., age, gender) factors will be considered. A machine learning (ML) based risk-modeling approach will be utilized to create the screening tool. For further external validation and clinical application, a freely accessible online tool and a mobile app will be developed based on the existing model.

Conditions

• Rheumatic Arthritis
• Interstitial Lung Disease in Patients With Rheumatoid Arthritis

Timeline

• Start date: 2024-11-11
• Primary completion: 2028-05-30
• Completion: 2029-09-30
• First posted: 2025-05-11
• Last updated: 2025-12-02

Locations

1 site across 1 country: Austria