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

Rheumatoid Arthritis Clinical Trial

— BERTHA  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04136223
• Other study ID #: BERTHA_IM101-839
• Status: Active, not recruiting
• Start date: March 1, 2021
• Est. completion date: May 31, 2024

Study information

• Verified date: June 2023
• Source: Hospital do Coracao
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Disease Progression
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pulmonary Fibrosis
• Rheumatoid Arthritis
• Rheumatoid Lung

Locations

Country	Name	City	State
Brazil	Hospital Universitário de Brasilia (HUB)	Brasília	DF
Brazil	Universidade Estadual de Campinas (UNICAMP)	Campinas
Brazil	LABOX - Federal University of Santa Catarina (UFSC)	Florianopolis
Brazil	LAPOGE - Federal University of Santa Catarina (UFSC)	Florianopolis
Brazil	Hospital das Clinicas - FMUSP	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
Hospital do Coracao	Boehringer Ingelheim, Bristol-Myers Squibb

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Interstitial Lung Disease progression - FVC	FVC longitudinal behavior (continuous variable)	2 years
Secondary	Interstitial Lung Disease progression - imaging	quantitative overall disease progression (continuous variable) & %VRS (vessel related structures) > 4.4% if access to CALIPER software	2 years
Secondary	Interstitial Lung Disease progression - death	Time to death or lung transplant	2 years
Secondary	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