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Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression (BERTHA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04136223
Recruitment Status : Not yet recruiting
First Posted : October 23, 2019
Last Update Posted : September 28, 2020
Sponsor:
Collaborators:
Bristol-Myers Squibb
DASA
Information provided by (Responsible Party):
Hospital do Coracao

Study Description
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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 protein biomarkers, genetic and clinical variables capable of identifying patients at risk of RA-ILD progression

Condition or disease
Rheumatoid Lung Rheumatoid Arthritis Interstitial Lung Disease Pulmonary Fibrosis

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, including blood protein biomarkers and genetic variables, with be identified.

Additionally, sub-phenotypes of RA-ILD will be investigated as well as their association with RA-ILD progression.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: BERTHA Study: Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression. A Multicenter, Observational Study
Estimated Study Start Date : January 1, 2021
Estimated Primary Completion Date : January 1, 2024
Estimated Study Completion Date : March 1, 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. Interstitial Lung Disease progression - continuous variable [ Time Frame: 2 years ]
    Quantitative analysis of the %ILD extent and % Vessel Related Structures (VRS) on the high-resolution computed tomography (HRCT) of the Chest


Secondary Outcome Measures :
  1. Interstitial Lung Disease progression - death [ Time Frame: 2 years ]
    Death

  2. Interstitial Lung Disease progression - dichotomous variables [ Time Frame: 2 years ]
    Proportion of patients with a change from baseline in the % vessel related structures (VSR) > 4.4% on the HRCT scan

  3. Interstitial Lung Disease progression - dichotomous variables [ Time Frame: 2 years ]
    Proportion of patients with a change from baseline in the %Forced Vital Capacity (FVC) greater or equal to 10%


Biospecimen Retention:   Samples With DNA
Blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
RA-ILD patients defined by altered imaging and associated functional derangements and/ or symptoms
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:

    1. Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit, or
    2. FVC<50% prediction or
    3. Carbon Monoxide diffusion (DLCO) <40% prediction

  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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04136223


Contacts
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Contact: Leticia Kawano Dourado, MD +55 11 3053-6611 ext 8209 ldourado@hcor.com.br
Contact: Beatriz Pacheco, BA/BS +55 11 3053-6611 ext 8209 bpacheco@hcor.com.br

Locations
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Brazil
Hospital Regional de Sobradinho
Brasília, DF, Brazil, 70297-400
Contact: Luciana Muniz, MD         
Principal Investigator: Luciana Muniz, MD         
Hospital Universitário de Brasilia (HUB)
Brasília, DF, Brazil, 70840-901
Contact: Licia Mota, MD         
Principal Investigator: Licia Mota, MD         
Universidade Estadual de Campinas (UNICAMP)
Campinas, SP, Brazil, 13083-872
Contact: Alisson Pugliesi, MD         
Principal Investigator: Alisson Pugliesi, MD         
Hospital das Clinicas - FMUSP
São Paulo, SP, Brazil, 05403-000
Contact: Karina Bonfiglioli, MD         
Principal Investigator: Karina Bonfiglioli, MD         
Sponsors and Collaborators
Hospital do Coracao
Bristol-Myers Squibb
DASA
More Information
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Responsible Party: Hospital do Coracao
ClinicalTrials.gov Identifier: NCT04136223    
Other Study ID Numbers: BERTHA_IM101-839
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: September 28, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Under development
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Lung Diseases
Pulmonary Fibrosis
Lung Diseases, Interstitial
Disease Progression
Joint Diseases
Musculoskeletal Diseases
 Pathologic Processes
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Disease Attributes
Respiratory Tract Diseases