Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Bristol-Myers Squibb | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Interstitial Lung Disease progression - FVC | FVC longitudinal behavior (continuous variable) | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Interstitial Lung Disease progression - imaging | quantitative overall disease progression (continuous variable) & %VRS (vessel related structures) > 4.4% if access to CALIPER software | 2 years |
| Interstitial Lung Disease progression - death |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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:
a. Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit
Presence of significant Arterial Pulmonary Hypertension:
Significant co-morbidity impacting respiratory system (e.g., congestive heart failure, lung neoplasm, active tuberculosis)
Not provided
Not provided
Not provided
RA-ILD patients defined by altered imaging and associated functional derangements and/ or symptoms
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Prof. Alexandra Latini, PhD | Federal University of Santa Catarina | Study Chair |
| Leticia Kawano-Dourado, MD | HCOR Research Institute, Hospital do Coracao, São Paulo, Brazil | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitário de Brasilia (HUB) | Brasília | Federal District | 70840-901 | Brazil | ||
| Hospital das Clinicas - FMUSP |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41760357 | Derived | 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. |
Not provided
Not provided
Under development
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D017563 | Lung Diseases, Interstitial |
| D011658 | Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Blood samples
Time to death or lung transplant
| 2 years |
| Interstitial Lung Disease progression - FVC dichotomous variable | Proportion of patients with a change from baseline in the %Forced Vital Capacity (FVC):
| 2 years |
| São Paulo |
| São Paulo |
| 05403-000 |
| Brazil |
| Universidade Estadual de Campinas (UNICAMP) | Campinas | Brazil |
| LABOX - Federal University of Santa Catarina (UFSC) | Florianópolis | Brazil |
| LAPOGE - Federal University of Santa Catarina (UFSC) | Florianópolis | Brazil |
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |