Rheumatoid LungBERTHANCT04136223
Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression
An observational study of Rheumatoid Lung and Rheumatoid Arthritis, run by Hospital do Coracao at 5 sites in Brazil.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Lung, Rheumatoid Arthritis, Interstitial Lung Disease
- How many people
- 100 participants
- Where
- 5 sitesBrazil
- Study dates
- 1 Mar 2021to 31 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: RA-ILD patients defined by altered imaging and associated functional derangements and/ or symptoms
Who may be able to join
- 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
Who cannot join
- 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:
- 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)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Brazil5 sites
Hospital Universitário de Brasilia (HUB)
Brasília, Federal District, 70840-901
Universidade Estadual de Campinas (UNICAMP)
Campinas
LABOX - Federal University of Santa Catarina (UFSC)
Florianópolis
LAPOGE - Federal University of Santa Catarina (UFSC)
Florianópolis
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 05403-000
About this study
Official title: BERTHA Study: Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression. A Multicenter, Observational Study
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
Read the 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.
- Medical subject headings
- Arthritis, Rheumatoid, Lung Diseases, Interstitial, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interstitial Lung Disease progression - FVC
FVC longitudinal behavior (continuous variable)
Measured: 2 years
Secondary outcomes (3)
Interstitial Lung Disease progression - imaging
quantitative overall disease progression (continuous variable) \& %VRS (vessel related structures) > 4.4% if access to CALIPER software
Measured: 2 years
Interstitial Lung Disease progression - death
Time to death or lung transplant
Measured: 2 years
Interstitial Lung Disease progression - FVC dichotomous variable
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
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start1 Mar 2021
- Primary completion31 May 2024 (estimated)
- Study completion31 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid LungStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital do Coracao
- Sponsor type
- University, hospital or other
- Collaborators
- Bristol-Myers Squibb, Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Prof. Alexandra Latini, PhD, Study chair, Federal University of Santa CatarinaLeticia Kawano-Dourado, MD, Study chair, HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136223
- Sponsor's protocol ID
- BERTHA_IM101-839
- Acronym
- BERTHA
- Status last verified
- Jun 2023
- First submitted
- 21 Oct 2019
- Last updated
- 29 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Under development
Publications
Kawano-Dourado L, Bonfiglioli K, Ribeiro ACM, Mota LMHD, Pugliesi A, Muniz L, Strabelli DG, Shimabuco AY, Lourenconi L, Riscado FLFBA, Pasoto SG, Albuquerque CP, Marqueze LF, Barros Costa Silva R, Palhares LC, Londe AC, Lindenau JD, Muniz YCN, Martins TRCM, Freitas ACR, Machado RHV, Veiga TS, Silva LO, Mendonca Dos Santos T, Tokunaga SM, Kodama DHK, Baldi B, Latini A, Valente Yamada Sawamura M. Functional, radiological and survival outcomes in rheumatoid arthritis-associated interstitial lung disease: 24-month results from the BERTHA prospective cohort. BMJ Open Respir Res. 2026 Feb 27;13(1):e003973. doi: 10.1136/bmjresp-2025-003973.
PubMed 41760357
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BERTHA Study: Rheumatoid Arthritis-Associated Interstitial Lung Disease: Characterization of Lung Disease Progression. A Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT04136223
- Acronym / sponsor ID
- BERTHA / BERTHA_IM101-839
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital do CoracaoUniversity, hospital or other
- Collaborators
- Bristol-Myers Squibb, Boehringer Ingelheim
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 31 May 2024 (estimated)
- Study completion
- 31 May 2024 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA-ILD patients defined by altered imaging and associated functional derangements and/ or symptoms
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
- Presence of significant Arterial Pulmonary Hypertension:
- Significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interstitial Lung Disease progression - FVC
Time frame: 2 years
FVC longitudinal behavior (continuous variable)
3 secondary outcomes
Interstitial Lung Disease progression - imaging
Time frame: 2 years
Interstitial Lung Disease progression - death
Time frame: 2 years
Interstitial Lung Disease progression - FVC dichotomous variable
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2023.
- Derived from this study: PubMed 41760357Kawano-Dourado L, Bonfiglioli K, Ribeiro ACM, Mota LMHD, Pugliesi A, Muniz L, Strabelli DG, Shimabuco AY, Lourenconi L, Riscado FLFBA, Pasoto SG, Albuquerque CP, Marqueze LF, Barros Costa Silva R, Palhares LC, Londe AC, Lindenau JD, Muniz YCN, Martins TRCM, Freitas ACR, Machado RHV, Veiga TS, Silva LO, Mendonca Dos Santos T, Tokunaga SM, Kodama DHK, Baldi B, Latini A, Valente Yamada Sawamura M. Functional, radiological and survival outcomes in rheumatoid arthritis-associated interstitial lung disease: 24-month results from the BERTHA prospective cohort. BMJ Open Respir Res. 2026 Feb 27;13(1):e003973. doi: 10.1136/bmjresp-2025-003973.
- Individual participant dataSharing planned: Yes. Under development
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Prof. Alexandra Latini, PhD study chair
Federal University of Santa Catarina
Leticia Kawano-Dourado, MD study chair
HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Lung and Rheumatoid Arthritis, run by Hospital do Coracao at 5 sites in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interstitial Lung Disease progression - FVC (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04136223, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jun 2023.