Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

May 25, 2022 updated by: dr.Kinga Fritsch, Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease With Radiographic and Labor Methods

The quantitative and qualitative analysis of RA lung involvement in the Hungarian population

Study Overview

Status

Recruiting

Conditions

Detailed Description

Interstitial lung disease (ILD) accounts for a significant proportion of mortality and morbidity in rheumatoid arthritis (RA). The aim of this prospective longitudinal study is to asess the interstitial lung involvement in Hungarian rheumatoid arthritis patients. Laboratory markers, X-ray based imaging methods, pulmonological functional tests, QOL questionnaire and sleep quality assessement questionnaire are used to estimate the interstitial lung disease. Also smaller cross-sectional studies about the imaging parameters and a national register is planned to be created based on these data.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Judit Majnik, MD PhD
  • Phone Number: +36306637976
  • Email: judit@majnik.hu

Study Locations

  • Hungary
      • Budapest, Hungary, 1023
        • Recruiting
        • Buda Hospital of the Hospitaller Order of Saint John of God
        • Contact:
          • Kinga Fritsch, MD
        • Contact:
          • Judit Majnik, MD PhD
        • Sub-Investigator:
          • György Nagy, MD PhD
        • Sub-Investigator:
          • Dóra Sárvári, MD
        • Sub-Investigator:
          • Tímea Petri
      • Budapest, Hungary, 1082
        • Recruiting
        • Medical Imaging Centre, Semmelweis University
        • Contact:
          • Nikolett Marton, MD, PhD
        • Contact:
          • János Gyebnár, MD
        • Sub-Investigator:
          • Pal Maurovich-Horvat, MD PhD MPH
        • Sub-Investigator:
          • Ádám Domonkos Tárnoki, MD PhD
        • Sub-Investigator:
          • Dávid László Tárnoki, MD PhD
        • Sub-Investigator:
          • László Szakács, MD
        • Sub-Investigator:
          • Leila Szeibel, MD
        • Sub-Investigator:
          • Klaudia Borbely, MD
      • Budapest, Hungary, 1083
        • Recruiting
        • Department of Pulmonology, Semmelweis University Faculty of Medicine
        • Contact:
          • Veronika Müller, MD PhD
        • Sub-Investigator:
          • Alexandra Nagy
        • Sub-Investigator:
          • Nóra Tóth
        • Sub-Investigator:
          • Tamás Nagy

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

RA patients with regular follow-ups at Polyclinic of Hospitaller Brothers of St. John of God, Budapest

Description

Inclusion Criteria:

  • diagnosis of RA

Exclusion Criteria:

  • pregnancy, breastfeeding
  • previous diagnosis of ILD, lung cancer, registered lung infection in the last 2 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of ILD
Time Frame: From baseline to at least 5 years
detection of ILD with imaging methods
From baseline to at least 5 years
pattern of ILD
Time Frame: From baseline to at least 5 years
to characterize the ILD patterns based on imaging methods
From baseline to at least 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation with biomarkers
Time Frame: From baseline to at least 2 years
correlation of the imaging results with respiratory function, disease activity and laboratory markers
From baseline to at least 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Polyclinic of the Hospitaller Brothers of St. John of God, Budapest

Collaborators

Medical Imaging Centre- Semmelweis University, Faculty of Medicine
Department of Pulmonology, Semmelweis University Faculty of Medicine

Investigators

  • Principal Investigator: Judit Majnik, MD PhD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 1, 2022

Primary Completion (ANTICIPATED)

December 1, 2026

Study Completion (ANTICIPATED)

December 1, 2026

Study Registration Dates

First Submitted

May 20, 2022

First Submitted That Met QC Criteria

May 20, 2022

First Posted (ACTUAL)

May 25, 2022

Study Record Updates

Last Update Posted (ACTUAL)

May 31, 2022

Last Update Submitted That Met QC Criteria

May 25, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IV/2683-1/2022/EKU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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