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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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)

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04136223
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Hospital do Coracao
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Prof. Alexandra Latini, PhDLeticia Kawano-Dourado, MD
Principal Investigator Affiliation Federal University of Santa CatarinaHCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Brazil
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Rheumatoid Lung, Rheumatoid Arthritis, Interstitial Lung Disease, Pulmonary Fibrosis
Additional Details

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.

Arms & Interventions

Arms

: RA-ILD

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

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hospital Universitário de Brasilia (HUB), Brasília, DF, Brazil

Status

Recruiting

Address

Hospital Universitário de Brasilia (HUB)

Brasília, DF, 70840-901

Site Contact

Licia Mota, MD

ldourado@hcor.com.br

+55 11 3053-6611

Hospital das Clinicas - FMUSP, Sao Paulo, SP, Brazil

Status

Recruiting

Address

Hospital das Clinicas - FMUSP

Sao Paulo, SP, 05403-000

Site Contact

Thelma G Carmo

pesqreumato.ichc@hc.fm.usp.br

+55 11 3053-6611

Campinas, Brazil

Status

Recruiting

Address

Universidade Estadual de Campinas (UNICAMP)

Campinas, ,

Site Contact

Alisson Pugliesi, MD

ldourado@hcor.com.br

+55 11 3053-6611

Florianopolis, Brazil

Status

Active, not recruiting

Address

LABOX - Federal University of Santa Catarina (UFSC)

Florianopolis, ,

Florianopolis, Brazil

Status

Active, not recruiting

Address

LAPOGE - Federal University of Santa Catarina (UFSC)

Florianopolis, ,