Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression

  • STATUS
    Recruiting
  • End date
    Apr 15, 2024
  • participants needed
    100
  • sponsor
    Hospital do Coracao
Updated on 29 April 2021

Summary

BERTHA studys primary objective is to characterize Rheumatoid Arthritis-associated Interstitial Lung Disease (RA-ILD) progression and to define a combination of biomarkers, genetic and clinical variables capable of identifying patients at risk of RA-ILD progression

Description

BERTHA is a multicentric, observational study that will enroll 100 RA-ILD patients to be followed for 2 years.

Interstitial Lung Disease (ILD) progression will be ascertained by quantitative image analysis and functional parameters. Variables associated with progression with be identified.

Additionally, RA-ILD endotypes will be investigated as well as their association with RA-ILD progression.

Details
Condition Pulmonary Disease, Lung Disease, Rheumatoid Arthritis, Rheumatoid Arthritis, Rheumatoid Arthritis (Pediatric), Pulmonary Fibrosis, Pulmonary Fibrosis, Interstitial lung disease, Rheumatoid Arthritis (Pediatric), Lung Disease, interstitial lung diseases, lung fibrosis, Rheumatoid Lung
Clinical Study IdentifierNCT04136223
SponsorHospital do Coracao
Last Modified on29 April 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Consecutive adult patients (aged >18 years) meeting RA diagnostic criteria in accordance with ACR 2010
Presence of interstitial lung disease 2.1 ILD Definition: presence of interstitial alterations in HRCT associated to functional derangements and/or symptoms
Patient agrees with having follow-up visits every 6 months for 2 years

Exclusion Criteria

Pregnancy or intending to become pregnant
Overlap with other diseases that occurs with ILD (other collagenoses, vasculitis, inflammatory bowel disease)
Presence of advanced ILD, characterized by
Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit
Presence of significant Arterial Pulmonary Hypertension
Evidence of Right ventricular failure evidence by echocardiography
Previous right chamber catheterism showing cardiac index < 2 liters/min/m
Significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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