Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease (MOUNTAIN)

University of Colorado Denver (CU Denver)

Status: Enrolling

Conditions: Interstitial Lung Disease; Rheumatoid Arthritis

Treatments: Other: Research Testing Performed; Genetic: Research Testing Performed (Laboratory); Diagnostic Test: Information Collected as Standard of Care

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06397677

1R01HL168126-01 (U.S. NIH Grant/Contract)

23-0295

Details and patient eligibility

About

A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression.

The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.

Full description

The central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. The hypothesis will be tested through collection and analysis of peripheral blood, in addition to the analysis of HRCT (high-resolution computed tomography) scans performed as standard of care (clinical) on research subjects.

Procedures performed:

Baseline Year 0: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs

Every 4 months (at clinic visit): Blood sample, questionnaires

Year 1 and Year 2 Follow-ups: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria
• 18 years of age or older

Exclusion criteria

• Prior medication treatment specifically for RA-ILD
• Inability to give informed consent
• Pregnant women

Trial design

450 participants in 1 patient group

Patients with RA-ILD

Description:

Assessments include: * Clinical: height, weight, oxygen saturation at rest, and 6-minute walk test. * Rheumatological: study Rheumatologist will document rheumatoid arthritis symptoms and clinical findings at baseline and follow-up. * Pulmonary Function Testing: data will be collected from clinically performed spirometry and diffusing capacity for carbon monoxide. * High-resolution computed tomography (HRCT) imaging: HRCT scans will be collected at baseline and 12 months in line with standard of care for treatment of RA-ILD. * Lab specimens: peripheral blood will be obtained for DNA, RNA, serum, and plasma at baseline and at 12 months for all sites or every 3-4 months in Colorado. Buccal swabs (cheek) will also be collected once each year. * Information collected: will include demographics, co-morbidities, disease history, medication history, pulmonary function, radiographic imaging, and transplant/survival status through questionnaires and medical chart review.

Treatment:

Other: Research Testing Performed

Diagnostic Test: Information Collected as Standard of Care

Genetic: Research Testing Performed (Laboratory)