Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis (REASSESS)

Medical University Innsbruck

Status: Enrolling

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

Study type: Observational

Funder types: Other

Identifiers

NCT06965322

EK Nr: 1086/2024

Details and patient eligibility

About

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).

Full 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.

Enrollment: 800 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.)