BERTHA study´s 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
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.
Study Type
OBSERVATIONAL
Enrollment
100
Hospital Universitário de Brasilia (HUB)
Brasília, Federal District, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Universidade Estadual de Campinas (UNICAMP)
Campinas, Brazil
LABOX - Federal University of Santa Catarina (UFSC)
Florianópolis, Brazil
Interstitial Lung Disease progression - FVC
FVC longitudinal behavior (continuous variable)
Time frame: 2 years
Interstitial Lung Disease progression - imaging
quantitative overall disease progression (continuous variable) \& %VRS (vessel related structures) \> 4.4% if access to CALIPER software
Time frame: 2 years
Interstitial Lung Disease progression - death
Time to death or lung transplant
Time frame: 2 years
Interstitial Lung Disease progression - FVC dichotomous variable
Proportion of patients with a change from baseline in the %Forced Vital Capacity (FVC): 1. greater or equal to 10% or 2. between 5 and 10% and worsening of symptoms
Time frame: 2 years
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LAPOGE - Federal University of Santa Catarina (UFSC)
Florianópolis, Brazil