Status:
UNKNOWN
Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression
Lead Sponsor:
Hospital do Coracao
Collaborating Sponsors:
Bristol-Myers Squibb
Boehringer Ingelheim
Conditions:
Rheumatoid Lung
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
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 varia...
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 an...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
March 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04136223
Start Date
March 1 2021
End Date
May 31 2024
Last Update
June 29 2023
Active Locations (5)
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1
Hospital Universitário de Brasilia (HUB)
Brasília, Federal District, Brazil, 70840-901
2
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil, 05403-000
3
Universidade Estadual de Campinas (UNICAMP)
Campinas, Brazil
4
LABOX - Federal University of Santa Catarina (UFSC)
Florianópolis, Brazil