Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

NCT ID: NCT05391100

Last Updated: 2022-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-01

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Rheumatoid Arthritis Interstitial Lung Disease

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* diagnosis of RA

Exclusion Criteria

* pregnancy, breastfeeding
* previous diagnosis of ILD, lung cancer, registered lung infection in the last 2 months
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medical Imaging Centre- Semmelweis University, Faculty of Medicine

UNKNOWN

Sponsor Role collaborator

Department of Pulmonology, Semmelweis University Faculty of Medicine

UNKNOWN

Sponsor Role collaborator

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

OTHER

Sponsor Role lead

Responsible Party

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dr.Kinga Fritsch

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Judit Majnik, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Locations

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Buda Hospital of the Hospitaller Order of Saint John of God

Budapest, , Hungary

Site Status RECRUITING

Medical Imaging Centre, Semmelweis University

Budapest, , Hungary

Site Status RECRUITING

Department of Pulmonology, Semmelweis University Faculty of Medicine

Budapest, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Kinga Fritsch, MD

Role: CONTACT

+36302892319

Judit Majnik, MD PhD

Role: CONTACT

+36306637976

Facility Contacts

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Kinga Fritsch, MD

Role: primary

Judit Majnik, MD PhD

Role: backup

Nikolett Marton, MD, PhD

Role: primary

János Gyebnár, MD

Role: backup

Veronika Müller, MD PhD

Role: primary

References

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Turesson C. Extra-articular rheumatoid arthritis. Curr Opin Rheumatol. 2013 May;25(3):360-6. doi: 10.1097/BOR.0b013e32835f693f.

Reference Type BACKGROUND
PMID: 23425964 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32794076 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27908535 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32141954 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23672718 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19892679 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26700157 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32591280 (View on PubMed)

Hata A, Yanagawa M, Honda O, Miyata T, Tomiyama N. Ultra-low-dose chest computed tomography for interstitial lung disease using model-based iterative reconstruction with or without the lung setting. Medicine (Baltimore). 2019 May;98(22):e15936. doi: 10.1097/MD.0000000000015936.

Reference Type BACKGROUND
PMID: 31145365 (View on PubMed)

National Lung Screening Trial Research Team; Aberle DR, Adams AM, Berg CD, Black WC, Clapp JD, Fagerstrom RM, Gareen IF, Gatsonis C, Marcus PM, Sicks JD. Reduced lung-cancer mortality with low-dose computed tomographic screening. N Engl J Med. 2011 Aug 4;365(5):395-409. doi: 10.1056/NEJMoa1102873. Epub 2011 Jun 29.

Reference Type BACKGROUND
PMID: 21714641 (View on PubMed)

Kauczor HU, Baird AM, Blum TG, Bonomo L, Bostantzoglou C, Burghuber O, Cepicka B, Comanescu A, Couraud S, Devaraj A, Jespersen V, Morozov S, Nardi Agmon I, Peled N, Powell P, Prosch H, Ravara S, Rawlinson J, Revel MP, Silva M, Snoeckx A, van Ginneken B, van Meerbeeck JP, Vardavas C, von Stackelberg O, Gaga M; European Society of Radiology (ESR) and the European Respiratory Society (ERS). ESR/ERS statement paper on lung cancer screening. Eur Respir J. 2020 Feb 12;55(2):1900506. doi: 10.1183/13993003.00506-2019. Print 2020 Feb.

Reference Type BACKGROUND
PMID: 32051182 (View on PubMed)

Peelen DM, Zwezerijnen BGJC, Nossent EJ, Meijboom LJ, Hoekstra OS, Van der Laken CJ, Voskuyl AE. The quantitative assessment of interstitial lung disease with positron emission tomography scanning in systemic sclerosis patients. Rheumatology (Oxford). 2020 Jun 1;59(6):1407-1415. doi: 10.1093/rheumatology/kez483.

Reference Type BACKGROUND
PMID: 31642912 (View on PubMed)

Nagy A, Nagy T, Kolonics-Farkas AM, Eszes N, Vincze K, Barczi E, Tarnoki AD, Tarnoki DL, Nagy G, Kiss E, Maurovich-Horvat P, Bohacs A, Muller V. Autoimmune Progressive Fibrosing Interstitial Lung Disease: Predictors of Fast Decline. Front Pharmacol. 2021 Dec 22;12:778649. doi: 10.3389/fphar.2021.778649. eCollection 2021.

Reference Type BACKGROUND
PMID: 35002713 (View on PubMed)

Barczi E, Nagy T, Starobinski L, Kolonics-Farkas A, Eszes N, Bohacs A, Tarnoki AD, Tarnoki DL, Muller V. Impact of interstitial lung disease and simultaneous lung cancer on therapeutic possibilities and survival. Thorac Cancer. 2020 Jul;11(7):1911-1917. doi: 10.1111/1759-7714.13481. Epub 2020 May 13.

Reference Type BACKGROUND
PMID: 32401433 (View on PubMed)

Croia C, Bursi R, Sutera D, Petrelli F, Alunno A, Puxeddu I. One year in review 2019: pathogenesis of rheumatoid arthritis. Clin Exp Rheumatol. 2019 May-Jun;37(3):347-357. Epub 2019 May 10.

Reference Type RESULT
PMID: 31111823 (View on PubMed)

Related Links

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Other Identifiers

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IV/2683-1/2022/EKU

Identifier Type: -

Identifier Source: org_study_id

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