Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

NCT03297775 | Recruiting

• 1 other identifier: 16-1097
• Study Type: observational
• Target: 750
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Presence of interstitial lung disease on high resolution CT (HRCT) chest imaging

  HRCT scans of the chest will be interpreted by two radiologists and the presence or absence of interstitial lung abnormality will be recorded. When present, abnormalities will be categorized as absent, equivocal, non-fibrotic, or fibrotic, and the extent of any reticular abnormalities will be graded on an 11-point scale (0, 1-10%, 11-20%, etc.). Additionally, the presence or absence of airway disease, centrilobular thickening, mosaic attenuation, and air trapping will be recorded.

  3-5 years

Secondary Outcomes (3)

• Progression of lung disease over time

  3-5 Years

• Impact of subclinical RA-ILD on health-related quality of life in RA

  3-5 Years

• Outcome of airways disease

  3-5 Years

Study Arms (2)

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.

Eligibility Criteria

• Age: 45 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk for the development of lung disease.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The following bio-specimens will be collected at baseline and at 3-5 years follow-up: * DNA (baseline only) * RNA * PBMC, Serum, Plasma

MeSH Terms

Conditions

Arthritis, Rheumatoid; Lung Diseases, Interstitial; Lung Diseases; Connective Tissue Diseases; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Respiratory Tract Diseases; Pulmonary Fibrosis

Study Officials

• Joyce S Lee, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Haylie A Lengel

CONTACT

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

Joyce S Lee, MD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 19, 2017
• First Posted: September 29, 2017
• Study Start: June 22, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)