Clinical trial NCT04136223: Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression
Official title: BERTHA Study: Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression. A Multicenter, Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Rheumatoid Lung
Rheumatoid Arthritis
Interstitial Lung Disease
Pulmonary Fibrosis
Lead sponsor: Hospital do Coracao
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Boehringer Ingelheim
First posted: 2019-10-23
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: RA-ILD patients defined by altered imaging and associated functional derangements and/ or symptoms

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Interstitial Lung Disease progression - FVC
timeFrame: 2 years
Secondary outcomes:
measure: Interstitial Lung Disease progression - imaging
timeFrame: 2 years
measure: Interstitial Lung Disease progression - death
timeFrame: 2 years
measure: Interstitial Lung Disease progression - FVC dichotomous variable
timeFrame: 2 years
Other outcomes:
Locations:
city: Brasília
country: Brazil
facility: Hospital Universitário de Brasilia (HUB)
state: DF
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: SP
city: Campinas
country: Brazil
facility: Universidade Estadual de Campinas (UNICAMP)
city: Florianopolis
country: Brazil
facility: LABOX - Federal University of Santa Catarina (UFSC)
city: Florianopolis
country: Brazil
facility: LAPOGE - Federal University of Santa Catarina (UFSC)
Study officials:
affiliation: Federal University of Santa Catarina
name: Prof. Alexandra Latini, PhD
role: STUDY_CHAIR
affiliation: HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
name: Leticia Kawano-Dourado, MD
role: STUDY_CHAIR
References: