NCT06397677

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 450 (estimated)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Rheumatoid Arthritis
• Interstitial Lung Disease

Interventions

Type	Name	Description
GENETIC	Research Testing Performed (Laboratory)	Blood collection (DNA, RNA)
DIAGNOSTIC_TEST	Information Collected as Standard of Care	High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)
OTHER	Research Testing Performed	Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires

Timeline

• Start date: 2024-01-22
• Primary completion: 2029-01-01
• Completion: 2034-01-01
• First posted: 2024-05-03
• Last updated: 2024-05-03

Locations

4 sites across 1 country: United States