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NCT Number: NCT05391100

Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

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

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Interstitial Lung Disease Joint Diseases Lung Diseases Lung Diseases, Interstitial Musculoskeletal Diseases Respiratory Tract Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Buda Hospital of the Hospitaller Order of Saint John of God, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • diagnosis of RA

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Prevalence of ILD

    Time frame: From baseline to at least 5 years

    detection of ILD with imaging methods

  2. pattern of ILD

    Time frame: From baseline to at least 5 years

    to characterize the ILD patterns based on imaging methods

Secondary outcomes

  1. 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

Study contacts

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

Judit Majnik, MD PhD

CONTACT

[email protected]

+36306637976

Kinga Fritsch, MD

CONTACT

[email protected]

+36302892319

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
May 25, 2022
Registry last updated
May 31, 2022

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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