Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT03297775

Conditions

Rheumatoid Arthritis

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Rheumatoid Arthritis

Interstitial Lung Disease

Study ID

NCT03297775

Start date

Jun 22, 2017

Status verified date

Apr, 2026

Completion date

Jun, 2027

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 45 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. ≥ 45years old
2. Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

1. Inability to give informed consent
2. Pregnant women
3. History of interstitial lung disease
4. Evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.
5. Subjects over the age of 90 years old or less than 45 years old

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

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

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 and Locations

Central contacts

Haylie A Lengel

970-376-8303haylie.lengel@cuanschutz.edu

Joyce S Lee, MD

303-724-6109joyce.lee@ucdenver.edu

Locations

University of Colorado - Anschutz Medical Campus

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Haylie A Lengel

970-376-8303haylie.lengel@cuanschutz.edu

Elizabeth O'Brien

303-875-1844elizabeth.a.obrien@cuanschutz.edu

Principal Investigator:

Joce Lee, MD

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 1, 2026

Last verified

Apr, 2026

Keywords

  • Rheumatoid Arthritis
  • RA
  • Interstitial Lung Disease
  • ILD
  • lung disease
  • connective tissue disease
  • CTD
  • idiopathic pulmonary fibrosis
  • IPF
  • airways disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2026-05-01.