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

Rheumatoid Arthritis Clinical Trial

— MOUNTAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06397677
• Other study ID #: 23-0295
• Secondary ID: 1R01HL168126-01
• Status: Recruiting
• Start date: January 22, 2024
• Est. completion date: January 2034

Study information

• Verified date: April 2024
• Source: University of Colorado, Denver
• Contact: Haylie Lengel
• Phone: 970-376-8303
• Email: haylie.lengel[@]cuanschutz.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: January 2034
• Est. primary completion date: January 2029
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	University of Colorado Denver	Aurora	Colorado
United States	University of Kansas	Kansas City	Kansas
United States	University of California San Francisco	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of Colorado, Denver	National Heart, Lung, and Blood Institute (NHLBI), University of California, San Francisco, University of Kansas, University of Michigan

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluating the role of novel quantitative imaging	Through evaluation of baseline CT scans and application of novel quantitative technology, investigators will monitor for specific patterning to identify patients at risk for progression.	5-years
Secondary	Comparing peripheral blood telomere length (PB-TL)	Investigators will test and validate if baseline peripheral blood telomere length (PB-TL) predicts a progressive phenotype in RA-ILD.	5-years
Secondary	Defining peripheral blood transcriptomic profiles	Investigators will define and validate the peripheral blood transcriptomic profile of progressive RA-ILD.	5-years
Secondary	Exploring if a composite profile more accurately identifies progressive RA-ILD	Investigators will use logistic least absolute shrinkage and selection operator (LASSO) to develop a predictive model of RA-ILD progression using demographics, novel imaging, PB-TL and peripheral blood transcriptome.	5-years