Rheumatic ArthritisREASSESSNCT06965322
Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis
An observational study of Rheumatic Arthritis and Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by Medical University Innsbruck at 1 site in Austria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatic Arthritis, Interstitial Lung Disease in Patients With Rheumatoid Arthritis
- How many people
- 800 participants
- Where
- 1 siteAustria
- Study dates
- 11 Nov 2024to 30 Sep 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
David Haschka, MD, PhD contact
Austria1 site, 1 recruiting
- Recruiting
Medical University Innsbruck
Innsbruck, Austria, 6020
Thomas Sonnweber, MD, PhD, +43(0)501250482586, Thomas.Sonnweber@i-med.ac.at
About this study
Official title: 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).
Read the 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.
- Keywords
- rheumatoid arthritis, interstitial lung disease, risk prediction, RA-ILD
- Medical subject headings
- Rheumatic Fever, Arthritis, Rheumatoid, Lung Diseases, Interstitial
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single point (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2025
- Study start11 Nov 2024
- Primary completion30 May 2028 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatic ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06965322
- Sponsor's protocol ID
- EK Nr: 1086/2024
- Acronym
- REASSESS
- Status last verified
- Nov 2025
- First submitted
- 11 Nov 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study on the Detection of Pleuropulmonary Manifestations in Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT06965322
- Acronym / sponsor ID
- REASSESS / EK Nr: 1086/2024
- Keywords
- rheumatoid arthritis, interstitial lung disease, risk prediction, RA-ILD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 11 Nov 2024 (actual)
- Primary completion
- 30 May 2028 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 11 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
David Haschka, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatic Arthritis and Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by Medical University Innsbruck at 1 site in Austria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Thomas Sonnweber, MD, PhD (+43(0)51250482586, Thomas.Sonnweber@i-med.ac.at), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of RA patients with pleuropulmonary involvement according to an AI-supported multiparametric risk profile analysis (time frame: single point (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025; AzTrials last refreshed its copy on 26 Oct 2026.