UnknownNot Applicable

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

Brazil100 participantsStarted 2021-03-01

Plain-language 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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)
✕. Presence of advanced ILD, characterized by:
✕. 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)

What they're measuring

Interstitial Lung Disease progression - FVC

Timeframe: 2 years

Trial details

NCT IDNCT04136223

SponsorHospital do Coracao

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-05-31

View on ClinicalTrials.gov More Rheumatoid Lung trials