Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis

Recruiting

• Conditions: Rheumatic Arthritis; Interstitial Lung Disease in Patients With Rheumatoid Arthritis

• Registration Number: NCT06965322
• Lead Sponsor: Medical University Innsbruck

Brief 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.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-11-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2025-05-09
• Last Update Submitted: 2025-05-09
• Study First Posted: 2025-05-11
• Last Update Posted: 2025-05-11
• Primary Completion: 2028-05-30
• Study Completion: 2029-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 800

Inclusion Criteria

• Patients ≥18 years diagnosed with rheumatoid arthritis according to current ACR/EULAR criteria
• Residence in Austria
• Signed and dated consent of the patient in accordance with ICH-GCP guidelines

Exclusion Criteria

• pregnancy
• age below 18 years
• Contraindications to study-related routine examinations (e.g., inability to draw blood due to needle phobia, no CT scan possible due to claustrophobia, pregnancy, etc.)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of RA patients with pleuropulmonary involvement according to an AI-supported multiparametric risk profile analysis	single point (baseline)	AI-supported risk factor-based analysis of pleuropulmonary involvement in RA patients assessed at a single time-point (baseline assessment). A multiparametric AI-supported evaluation based on clinical, sonographic, pulmonary function, laboratory, and exercise performance tests defines an RA population at high risk for the presence of pleuropulmonary involvement.

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Austria