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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-01

Study Completion Date

2024-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Deciphering Rheumatoid Arthritis-associated Interstitial Lung Disease Pathogenesis 2

NCT04227535

Rheumatoid Arthritis Interstitial Lung Disease

ACTIVE_NOT_RECRUITING

Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

NCT03297775

Rheumatoid Arthritis Interstitial Lung Disease

RECRUITING

Rheumatoid Arthritis-associated Interstitial Lung Disease Definition

NCT06184893

Rheumatoid Arthritis-Associated Interstitial Lung Disease

RECRUITING

Interstitial Lung Disease in Early Rheumatoid Arthritis

NCT03977415

Rheumatoid Arthritis Interstitial Lung Disease

UNKNOWN

Investigation on Risk Factors of Rheumatoid Arthritis Related Interstitial Lung Disease

NCT06036537

Rheumatoid Arthritis Associated Interstitial Lung Disease

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Rheumatoid Lung Rheumatoid Arthritis Interstitial Lung Disease Pulmonary Fibrosis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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:

a. Dyspnea rated as modified Medical Research Council 4 (mMRC4) on routine visit
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, active tuberculosis)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No