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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Rheumatoid Lung, Rheumatoid Arthritis, Interstitial Lung Disease, Pulmonary Fibrosis

Participation Criteria
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Eligibility Criteria
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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: a. 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/m² Significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RA-ILD<br>Consecutive adult patients (aged >18 years) with RA* and interstitial lung disease *in accordance with the American College of Rheumatology (ACR) classification criteria of 2010 | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Lung Disease progression - FVC | FVC longitudinal behavior (continuous variable) | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interstitial Lung Disease progression - imaging | quantitative overall disease progression (continuous variable) & %VRS (vessel related structures) > 4.4% if access to CALIPER software | 2 years | 
| Interstitial Lung Disease progression - death | Time to death or lung transplant | 2 years | 
| Interstitial Lung Disease progression - FVC dichotomous variable | Proportion of patients with a change from baseline in the %Forced Vital Capacity (FVC): greater or equal to 10% or between 5 and 10% and worsening of symptoms | 2 years |