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

BERTHA Study: Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression. A Multicenter, Observational Study

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.

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)