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Recruiting NCT05391100

Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

Observational Rheumatoid Arthritis Interstitial Lung Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis, Interstitial Lung Disease. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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

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.

Primary outcome measures

  • Prevalence of ILD [Time frame: From baseline to at least 5 years]
  • pattern of ILD [Time frame: From baseline to at least 5 years]
Secondary outcome measures (1)
  • Correlation with biomarkers [Time frame: From baseline to at least 2 years]

Eligibility criteria

Inclusion criteria

  • diagnosis of RA

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

Hungary · 3 centers
  • Buda Hospital of the Hospitaller Order of Saint John of God — Budapest
  • Medical Imaging Centre, Semmelweis University — Budapest
  • Department of Pulmonology, Semmelweis University Faculty of Medicine — Budapest

Publications

  • Turesson C. Extra-articular rheumatoid arthritis. Curr Opin Rheumatol. 2013 May;25(3):360-6. doi: 10.1097/BOR.0b013e32835f693f. PMID 23425964
  • Dai Y, Wang W, Yu Y, Hu S. Rheumatoid arthritis-associated interstitial lung disease: an overview of epidemiology, pathogenesis and management. Clin Rheumatol. 2021 Apr;40(4):1211-1220. doi: 10.1007/s10067-020-05320-z. Epub 2020 Aug 13. PMID 32794076
  • Avouac J, Amrouche F, Meune C, Rey G, Kahan A, Allanore Y. Mortality profile of patients with rheumatoid arthritis in France and its change in 10 years. Semin Arthritis Rheum. 2017 Apr;46(5):537-543. doi: 10.1016/j.semarthrit.2016.10.007. Epub 2016 Oct 29. PMID 27908535
  • England BR, Hershberger D. Management issues in rheumatoid arthritis-associated interstitial lung disease. Curr Opin Rheumatol. 2020 May;32(3):255-263. doi: 10.1097/BOR.0000000000000703. PMID 32141954
  • Hodnett PA, Naidich DP. Fibrosing interstitial lung disease. A practical high-resolution computed tomography-based approach to diagnosis and management and a review of the literature. Am J Respir Crit Care Med. 2013 Jul 15;188(2):141-9. doi: 10.1164/rccm.201208-1544CI. PMID 23672718
  • Kim EJ, Collard HR, King TE Jr. Rheumatoid arthritis-associated interstitial lung disease: the relevance of histopathologic and radiographic pattern. Chest. 2009 Nov;136(5):1397-1405. doi: 10.1378/chest.09-0444. PMID 19892679
  • Salvatore M, Henschke CI, Yip R, Jacobi A, Eber C, Padilla M, Knoll A, Yankelevitz D. JOURNAL CLUB: Evidence of Interstitial Lung Disease on Low-Dose Chest CT Images: Prevalence, Patterns, and Progression. AJR Am J Roentgenol. 2016 Mar;206(3):487-94. doi: 10.2214/AJR.15.15537. Epub 2015 Dec 23. PMID 26700157
  • Ley S, Fidler L, Schenk H, Durand M, Marras T, Paul N, Shapera S, Mittoo S. Low dose computed tomography of the lung for detection and grading of interstitial lung disease: A systematic simulation study. Pulmonology. 2021 Jan-Feb;27(1):14-25. doi: 10.1016/j.pulmoe.2020.06.004. Epub 2020 Jun 24. PMID 32591280

Identifiers

NCT: NCT05391100 · IV/2683-1/2022/EKU

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗