Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression (BERTHA)

Hospital do Coracao

Status: Active, not recruiting

Conditions: Pulmonary Fibrosis; Rheumatoid Lung; Interstitial Lung Disease; Rheumatoid Arthritis

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04136223

BERTHA_IM101-839

Details and patient eligibility

About

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

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

100 participants in 1 patient group

RA-ILD

Description:

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