Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05391100
• Other study ID #: IV/2683-1/2022/EKU
• Status: Recruiting
• Start date: February 1, 2022
• Est. completion date: December 2026

Study information

• Verified date: May 2022
• Source: Polyclinic of the Hospitaller Brothers of St. John of God, Budapest
• Contact: Kinga Fritsch, MD
• Phone: +36302892319
• Email: kflinta[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of RA

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Hungary	Buda Hospital of the Hospitaller Order of Saint John of God	Budapest
Hungary	Department of Pulmonology, Semmelweis University Faculty of Medicine	Budapest
Hungary	Medical Imaging Centre, Semmelweis University	Budapest

Sponsors (3)

Lead Sponsor	Collaborator
Polyclinic of the Hospitaller Brothers of St. John of God, Budapest	Department of Pulmonology, Semmelweis University Faculty of Medicine, Medical Imaging Centre- Semmelweis University, Faculty of Medicine

Country where clinical trial is conducted

Hungary, 

References & Publications (15)

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. — View Citation

Barczi E, Nagy T, Starobinski L, Kolonics-Farkas A, Eszes N, Bohacs A, Tarnoki AD, Tarnoki DL, Müller 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. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. Review. — View Citation

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. — View Citation

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. Review. — View Citation

Kauczor HU, Baird AM, Blum TG, Bonomo L, Bostantzoglou C, Burghuber O, Cepická 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). pii: 1900506. doi: 10.1183/13993003.00506-2019. Print 2020 Feb. — View Citation

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. Review. — View Citation

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. — View Citation

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, Müller 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of ILD	detection of ILD with imaging methods	From baseline to at least 5 years
Primary	pattern of ILD	to characterize the ILD patterns based on imaging methods	From baseline to at least 5 years
Secondary	Correlation with biomarkers	correlation of the imaging results with respiratory function, disease activity and laboratory markers	From baseline to at least 2 years

External Links

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