AzTrials
AzTrials

Rheumatoid ArthritisNCT05391100

Screening of Patients With Rheumatoid Arthritis for Interstitial Lung Disease

An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 3 sites in Hungary.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The quantitative and qualitative analysis of RA lung involvement in the Hungarian population Read more about this study

Who is it for?
Ages 40 years and older
How many people
500 participants
Where
3 sitesHungary
Study dates
1 Feb 2022to Dec 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • diagnosis of RA

Who cannot join

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

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kinga Fritsch, MD contact

+36302892319

kflinta@hotmail.com

Judit Majnik, MD PhD contact

+36306637976

judit@majnik.hu

Hungary3 sites, 3 recruiting

  • Buda Hospital of the Hospitaller Order of Saint John of God

    Budapest, 1023

    Kinga Fritsch, MD

    Judit Majnik, MD PhD

    Recruiting

  • Medical Imaging Centre, Semmelweis University

    Budapest, 1082

    Nikolett Marton, MD, PhD

    János Gyebnár, MD

    Recruiting

  • Department of Pulmonology, Semmelweis University Faculty of Medicine

    Budapest, 1083

    Veronika Müller, MD PhD

    Alexandra Nagy

    Recruiting

Other trials in Hungary

About this study

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

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

Read the 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.

Keywords
rheumatoid arthritis, Interstitial Lung Disease
Medical subject headings
Arthritis, Rheumatoid, Lung Diseases, Interstitial

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Prevalence of ILD

    detection of ILD with imaging methods

    Measured: From baseline to at least 5 years

  2. pattern of ILD

    to characterize the ILD patterns based on imaging methods

    Measured: From baseline to at least 5 years

Secondary outcomes (1)

  1. Correlation with biomarkers

    correlation of the imaging results with respiratory function, disease activity and laboratory markers

    Measured: From baseline to at least 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 May 2022
  2. Study start1 Feb 2022
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05391100
Sponsor's protocol ID
IV/2683-1/2022/EKU
Status last verified
May 2022
First submitted
20 May 2022
Last updated
31 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

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

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 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.

    PubMed 32591280

  • 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.

    PubMed 31145365

  • 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.

    PubMed 21714641

  • 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.

    PubMed 32051182

  • 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.

    PubMed 31642912

  • 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.

    PubMed 35002713

  • 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.

    PubMed 32401433

  • 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.

    PubMed 31111823

Questions about this trial

What is this clinical trial studying?

An observational study of Rheumatoid Arthritis and Interstitial Lung Disease, run by Polyclinic of the Hospitaller Brothers of St. John of God, Budapest at 3 sites in Hungary.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Kinga Fritsch, MD (+36302892319, kflinta@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of ILD (time frame: From baseline to at least 5 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05391100, which also lists 16 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.

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