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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of Colorado, Denver
Study ID
NCT06397677
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Jan 22, 2024
Status verified
Apr 2024
Primary completion
Jan 31, 2029
Completion
Jan 31, 2034

Study Design

Enrollment
450 participants (estimated)

Arms

  • Arm: Patients with RA-ILD
    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 Measure

Evaluating the role of novel quantitative imaging [ Time Frame: 5-years ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
University of California San FranciscoSan FranciscoCalifornia94143
Paul Wolters, MD
University of Colorado DenverAuroraColorado80045
Haylie A Lengel
[email protected]
970-376-8303
Joyce S Lee, MD (PRINCIPAL_INVESTIGATOR)
University of KansasKansas CityKansas66103
Scott Matson, MD
University of MichiganAnn ArborMichigan48109
Justin Oldham, MD

Find similar trials in San Francisco, CA

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of California San Francisco· San Francisco, CAUniversity of Colorado Denver· Aurora, COUniversity of Kansas· Kansas City, KSUniversity of Michigan· Ann Arbor, MI

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