Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

Part of paid clinical trials in Aurora, Colorado.

Sponsor
University of Colorado, Denver
Study ID
NCT03297775
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Study Details

The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD), and identify factors that predict radiologic progression in those with subclinical RA-ILD, in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common core elements (e.g. clinical features, genetic variants, and/or biologic markers) between other forms of ILD (e.g. idiopathic pulmonary fibrosis, IPF) and subclinical RA-ILD that places individuals at risk for the development of lung disease.

Key Dates

Start date
Jun 22, 2017
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
750 participants (estimated)

Arms

  • Arm: RA with Sub-clinical ILD
    Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers
  • Arm: RA with No-ILD
    Subjects will be followed annually until study closure. Assessments are as follows: 1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life 2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) 3. Radiologic (3-5 yrs FU): HRCT scan of chest 4. Genetic (3-5 yrs FU): Blood sample collection for RNA 5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers Note: Certain follow-up procedures may not occur for every subject and will be determined by the research team.

Primary Outcome Measure

Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging [ Time Frame: 3-5 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Colorado - Anschutz Medical CampusAuroraColorado80045
Haylie A Lengel
[email protected]
970-376-8303
Elizabeth O'Brien
[email protected]
303-875-1844
Joce Lee, MD (PRINCIPAL_INVESTIGATOR)
Kristen Demoruelle, MD (SUB_INVESTIGATOR)
Jason Kolfenbach, MD (SUB_INVESTIGATOR)
Duane Pearson, MD (SUB_INVESTIGATOR)
Kevin Deane, MD (SUB_INVESTIGATOR)

Find similar trials in Aurora, CO

By condition
Rheumatoid arthritis
By specialty
RheumatologyAutoimmune diseaseMusculoskeletal disorders
By research site
University of Colorado - Anschutz Medical Campus· Aurora, CO

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