Actively Recruiting
Prospective Observational Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis
Led by Medical University Innsbruck · Updated on 2025-12-02
800
Participants Needed
1
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying pleuropulmonary manifestations in patients with rheumatoid arthritis (RA) to develop a standardized, risk-adapted screening protocol. This study aims to better detect lung and pleural involvement in RA by evaluating a wide range of clinical, functional, and demographic factors. The research includes using machine learning to create a tool that helps assess risk based on these factors. Participants will undergo thorough clinical evaluations by pulmonology and rheumatology specialists, including standardized disease activity and symptom scoring. Laboratory tests such as RF, ACPA, CRP, and CEA will be collected, alongside lung function tests like body plethysmography, TLCO, FeNO, and the six-minute walk test. Ultrasound examinations of the thorax and joints will also be performed. The study plans to use the collected data to develop a machine learning-based risk model, which will be made available as an online tool and mobile app for clinical use. During the study, participants will receive comprehensive clinical and laboratory assessments to collect data on lung involvement. Researchers will measure the number of RA patients with pleuropulmonary manifestations using an AI-supported multiparametric risk profile analysis at baseline. The study is observational, with no treatment interventions, and participants will be closely monitored through these evaluations. The study will continue until September 2029, allowing for thorough data gathering and validation of the screening tool.
CONDITIONS
Brief Title
Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years or older 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
You will not qualify if you...
- Pregnancy
- Age below 18 years
- Contraindications to study-related routine examinations such as inability to draw blood due to needle phobia, no CT scan possible due to claustrophobia, or pregnancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single point (baseline)
Participants undergo clinical, laboratory, lung function, and sonographic assessments to detect pleuropulmonary manifestations in rheumatoid arthritis.
1 visit (in-person)
Duration - Up to study completion in September 2029
Participants are observed to validate the risk-adapted screening protocol and support clinical application.
Visits as needed depending on clinical follow-up
Trial Site Locations
Total: 1 location
1
Medical University Innsbruck
Innsbruck, Austria, Austria, 6020
Actively Recruiting
Research Team
T
Thomas Sonnweber, MD, PhD
D
David Haschka, MD, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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