Interstitial Lung Disease, Pulmonary Fibrosis, Rheumatoid Arthritis, Rheumatoid Lung
Conditions
Brief summary
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
Detailed 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.
Interventions
None listed
Sponsors
Bristol-Myers Squibb
Boehringer Ingelheim
Hospital do Coracao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Consecutive adult patients (aged \>18 years) meeting RA diagnostic criteria in accordance with ACR 2010 2. Presence of interstitial lung disease 2.1 ILD Definition: presence of interstitial alterations in HRCT associated to functional derangements and/or symptoms 3. Patient agrees with having follow-up visits every 6 months for 2 years
Exclusion criteria
1. Pregnancy or intending to become pregnant 2. Overlap with other diseases that occurs with ILD (other collagenoses, vasculitis, inflammatory bowel disease) 3. Presence of advanced ILD, characterized by: a. Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit 4. Presence of significant Arterial Pulmonary Hypertension: 1. Evidence of Right ventricular failure evidence by echocardiography 2. Previous right chamber catheterism showing cardiac index \< 2 liters/min/m² 5. Significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Interstitial Lung Disease progression - FVC | 2 years | FVC longitudinal behavior (continuous variable) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Interstitial Lung Disease progression - imaging | 2 years | quantitative overall disease progression (continuous variable) & %VRS (vessel related structures) \> 4.4% if access to CALIPER software |
| Interstitial Lung Disease progression - death | 2 years | Time to death or lung transplant |
| Interstitial Lung Disease progression - FVC dichotomous variable | 2 years | 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 |
Countries
Brazil
Outcome results
None listed