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

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

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).

Study Overview

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

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 Type: Observational
• Enrollment (Estimated): 800

Contacts and Locations

• Study Contact: Name: Thomas Sonnweber, MD, PhD; Phone Number: +43(0)51250482586; Email: Thomas.Sonnweber@i-med.ac.at
• Study Contact Backup: Name: David Haschka, MD, PhD; Email: david.haschka@i-med.ac.at

Study Locations

• Austria
  • Austria
    • Innsbruck, Austria, Austria, 6020
      • Recruiting
      • Medical University Innsbruck
      • Contact: Thomas Sonnweber, MD, PhD; Phone Number: +43(0)501250482586; Email: Thomas.Sonnweber@i-med.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients aged 18 years or older, currently residing in Austria, diagnosed with rheumatoid arthritis according to the current ACR/EULAR criteria, will be eligible for study entry.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of RA patients with pleuropulmonary involvement according to an AI-supported multiparametric risk profile analysis	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.	single point (baseline)

Collaborators and Investigators

• Sponsor: Medical University Innsbruck

Study record dates

Study Major Dates

• Study Start (Actual): November 11, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): September 30, 2029

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: May 9, 2025
• First Posted (Actual): May 11, 2025

Study Record Updates

• Last Update Posted (Actual): December 2, 2025
• Last Update Submitted That Met QC Criteria: December 1, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; interstitial lung disease; risk prediction; RA-ILD
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Infections; Respiratory Tract Diseases; Lung Diseases; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Skin and Connective Tissue Diseases; Lung Diseases, Interstitial; Arthritis, Rheumatoid; Rheumatic Fever
• Other Study ID Numbers: EK Nr: 1086/2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No