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

Recruiting

• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease
• Interventions: Genetic: Research Testing Performed (Laboratory); Diagnostic Test: Information Collected as Standard of Care; Other: Research Testing Performed

• Registration Number: NCT06397677
• Lead Sponsor: University of Colorado, Denver

Brief 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

Study Timeline

• Study First Submitted: 2023-12-01
• Study Start: 2024-01-22
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-29
• Last Update Submitted: 2024-04-29
• Study First Posted: 2024-05-03
• Last Update Posted: 2024-05-03
• Primary Completion: 2029-01
• Study Completion: 2034-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with RA-ILD	Information Collected as Standard of Care	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.
Patients with RA-ILD	Research Testing Performed	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.
Patients with RA-ILD	Research Testing Performed (Laboratory)	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.

Primary Outcome Measures

Name	Time	Method
Evaluating the role of novel quantitative imaging	5-years	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.

Secondary Outcome Measures

Name	Time	Method
Comparing peripheral blood telomere length (PB-TL)	5-years	Investigators will test and validate if baseline peripheral blood telomere length (PB-TL) predicts a progressive phenotype in RA-ILD.
Defining peripheral blood transcriptomic profiles	5-years	Investigators will define and validate the peripheral blood transcriptomic profile of progressive RA-ILD.
Exploring if a composite profile more accurately identifies progressive RA-ILD	5-years	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.

Trial Locations

Locations (4)

University of Kansas; 🇺🇸 Kansas City, Kansas, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

University of California San Francisco; 🇺🇸 San Francisco, California, United States

University of Colorado Denver; 🇺🇸 Aurora, Colorado, United States