Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

Overview

The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common elements between other forms of ILD such as idiopathic pulmonary fibrosis (IPF) and sub-clinical RA-ILD that places individuals at risk for the development of lung disease.

This is not a treatment study. It is a protocol designed to enroll individuals affected by RA and explore associated lung disease so that the investigators can better understand the clinical phenotype and genetic and molecular endotypes of this disease.

Study Type

  • Study Type: Observational [Patient Registry]
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2027

Arms, Groups and Cohorts

  • Evidence of interstitial lung disease
    • Subjects who screen positive for ILD will be followed annually until study closure. Assessments are as follows: Clinical – Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) Physiologic – Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance Radiologic – Assessment for airways disease, interstitial lung abnormalities Genetic – DNA, RNA Biologic – Serum, Plasma, Sputum
  • No evidence of interstitial lung disease
    • Subjects who screen negative for ILD will be followed five years after the initial screen and re-screened with a chest CT scan to check for evidence of new lung disease. Assessments are as follows: Clinical – Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment) Physiologic – Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance Radiologic – Assessment for airways disease, interstitial lung abnormalities Genetic – DNA, RNA Biologic – Serum, Plasma, Sputum

Clinical Trial Outcome Measures

Primary Measures

  • Presence or absence of interstitial lung disease on high resolution CT (HRCT) imaging
    • Time Frame: 10 years
    • This study is designed to evaluate individuals affected by RA and explore associated lung disease so that the investigators can better understand the clinical phenotype and genetic and molecular endotypes of this disease.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria

Exclusion Criteria

  • Inability to give informed consent
  • Pregnant women
  • History of Interstitial Lung Disease
  • Evidence of other cause of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Colorado, Denver
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Joyce S Lee, MD, Principal Investigator, University of Colorado, Denver
  • Overall Contact(s)
    • Lina Stanchev, MS, 303-724-9469, LINA.STANCHEV@UCDENVER.EDU

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