Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis

NCT06965322 | Recruiting

• 1 other identifier: EK Nr: 1086/2024
• Study Type: observational
• Target: 800
• Locations: 1 country
• Sites: 1

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).

Conditions

Rheumatic Arthritis; Interstitial Lung Disease in Patients With Rheumatoid Arthritis

Keywords

rheumatoid arthritis; interstitial lung disease; risk prediction; RA-ILD

Outcome Measures

Primary Outcomes (1)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Medical University Innsbruck: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Austria, 6020, Austria

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

blood sample collection

MeSH Terms

Conditions

Rheumatic Fever; Arthritis, Rheumatoid; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Thomas Sonnweber, MD, PhD

CONTACT

+43(0)51250482586; Thomas.Sonnweber@i-med.ac.at

David Haschka, MD, PhD

CONTACT

david.haschka@i-med.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: May 11, 2025
• Study Start: November 11, 2024
• Primary Completion (Estimated): May 30, 2028
• Study Completion (Estimated): September 30, 2029
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

AU (1)