Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

NCT05391100 | Recruiting

• 1 other identifier: IV/2683-1/2022/EKU
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Rheumatoid Arthritis; Interstitial Lung Disease

Keywords

rheumatoid arthritis; Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

• Prevalence of ILD

  detection of ILD with imaging methods

  From baseline to at least 5 years

• pattern of ILD

  to characterize the ILD patterns based on imaging methods

  From baseline to at least 5 years

Secondary Outcomes (1)

• Correlation with biomarkers

  From baseline to at least 2 years

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• diagnosis of RA

You may not qualify if:

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

Sponsors & Collaborators

• Polyclinic of the Hospitaller Brothers of St. John of God, Budapest: lead
• Medical Imaging Centre- Semmelweis University, Faculty of Medicine: collaborator
• Department of Pulmonology, Semmelweis University Faculty of Medicine: collaborator

Study Sites (3)

Buda Hospital of the Hospitaller Order of Saint John of God

Budapest, 1023, Hungary

RECRUITING

Medical Imaging Centre, Semmelweis University

Budapest, 1082, Hungary

RECRUITING

Department of Pulmonology, Semmelweis University Faculty of Medicine

Budapest, 1083, Hungary

RECRUITING

Related Publications (15)

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

  PMID: 23425964 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 31145365 BACKGROUND

• 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.

  PMID: 21714641 BACKGROUND

• 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.

  PMID: 32051182 BACKGROUND

• 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.

  PMID: 31642912 BACKGROUND

• 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.

  PMID: 35002713 BACKGROUND

• 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.

  PMID: 32401433 BACKGROUND

• 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.

  PMID: 31111823 RESULT

Related Links

• legislation
• Research Article

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum for biomarkers

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Judit Majnik, MD PhD

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kinga Fritsch, MD

CONTACT

+36302892319; kflinta@hotmail.com

Judit Majnik, MD PhD

CONTACT

+36306637976; judit@majnik.hu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 20, 2022
• First Posted: May 25, 2022
• Study Start: February 1, 2022
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 31, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

HU (3)