Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression (BERTHA)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04136223 |
Recruitment Status :
Active, not recruiting
First Posted : October 23, 2019
Last Update Posted : August 9, 2022
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Condition or disease |
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Rheumatoid Lung Rheumatoid Arthritis Interstitial Lung Disease Pulmonary Fibrosis |
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.
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 |
Actual Study Start Date : | March 1, 2021 |
Estimated Primary Completion Date : | May 31, 2024 |
Estimated Study Completion Date : | May 31, 2024 |

Group/Cohort |
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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 |
- Interstitial Lung Disease progression - FVC [ Time Frame: 2 years ]FVC longitudinal behavior (continuous variable)
- Interstitial Lung Disease progression - imaging [ Time Frame: 2 years ]quantitative overall disease progression (continuous variable) & %VRS (vessel related structures) > 4.4% if access to CALIPER software
- Interstitial Lung Disease progression - death [ Time Frame: 2 years ]Time to death or lung transplant
- Interstitial Lung Disease progression - FVC dichotomous variable [ Time Frame: 2 years ]
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
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
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 |
Inclusion Criteria:
- 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 Criteria:
- Pregnancy or intending to become pregnant
- Overlap with other diseases that occurs with ILD (other collagenoses, vasculitis, inflammatory bowel disease)
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Presence of advanced ILD, characterized by:
a. Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit
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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)

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
Brazil | |
Hospital Universitário de Brasilia (HUB) | |
Brasília, DF, Brazil, 70840-901 | |
Hospital das Clinicas - FMUSP | |
Sao Paulo, SP, Brazil, 05403-000 | |
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 |
Study Chair: | Prof. Alexandra Latini, PhD | Federal University of Santa Catarina | |
Study Chair: | Leticia Kawano-Dourado, MD | HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil |
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: | August 9, 2022 |
Last Verified: | August 2022 |
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 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
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 Respiratory Tract Diseases Disease Attributes |