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

Active, not recruiting

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

• Registration Number: NCT04136223
• Lead Sponsor: Hospital do Coracao

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.

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2021-03-01
• Status Verified: 2023-06
• Last Update Submitted: 2023-06-28
• Last Update Posted: 2023-06-29
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interstitial Lung Disease progression - FVC	2 years	FVC longitudinal behavior (continuous variable)

Secondary Outcome Measures

Name	Time	Method
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 - 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
Interstitial Lung Disease progression - death	2 years	Time to death or lung transplant

Trial Locations

Locations (5)

Universidade Estadual de Campinas (UNICAMP); 🇧🇷 Campinas, Brazil

Hospital Universitário de Brasilia (HUB); 🇧🇷 Brasília, DF, Brazil

LABOX - Federal University of Santa Catarina (UFSC); 🇧🇷 Florianopolis, Brazil

Hospital das Clinicas - FMUSP; 🇧🇷 Sao Paulo, SP, Brazil

LAPOGE - Federal University of Santa Catarina (UFSC); 🇧🇷 Florianopolis, Brazil