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NCT Number: NCT06965322

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).

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Key information

Conditions

Rheumatic Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Bacterial Infections Bacterial Infections and Mycoses Connective Tissue Diseases Gram-Positive Bacterial Infections Immune System Diseases Infections Interstitial Lung Disease in Patients With Rheumatoid Arthritis Joint Diseases Lung Diseases Lung Diseases, Interstitial Musculoskeletal Diseases Respiratory Tract Diseases Rheumatic Diseases Rheumatic Fever Skin and Connective Tissue Diseases Streptococcal Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

Primary outcomes

  1. Number of RA patients with pleuropulmonary involvement according to an AI-supported multiparametric risk profile analysis

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Haschka, MD, PhD

CONTACT

[email protected]

Thomas Sonnweber, MD, PhD

CONTACT

[email protected]

+43(0)51250482586

Sponsors and collaborators

Lead sponsor

Medical University Innsbruck

Other

Registry information

Official study title

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

Acronym: REASSESS

Important dates

Study start
2024
Primary completion
2028
Study completion
2029
First posted
May 11, 2025
Registry last updated
Dec 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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