Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis; Interstitial Lung Disease

• Study Type: Observational
• Enrollment (Estimated): 750

Contacts and Locations

• Study Contact: Name: Haylie A Lengel; Phone Number: 970-376-8303; Email: haylie.lengel@cuanschutz.edu
• Study Contact Backup: Name: Joyce S Lee, MD; Phone Number: 303-724-6109; Email: joyce.lee@ucdenver.edu

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Recruiting
      • University of Colorado - Anschutz Medical Campus
      • Contact: Haylie A Lengel; Phone Number: 970-376-8303; Email: haylie.lengel@cuanschutz.edu
      • Principal Investigator: Joce Lee, MD
      • Sub-Investigator: Kristen Demoruelle, MD
      • Sub-Investigator: Jason Kolfenbach, MD
      • Sub-Investigator: Duane Pearson, MD
      • Sub-Investigator: Kevin Deane, MD
      • Contact: Elizabeth O'Brien; Phone Number: 303-875-1844; Email: elizabeth.a.obrien@cuanschutz.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
RA with Sub-clinical ILD; Subjects will be followed annually until study closure. Assessments are as follows: Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life; Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT); Radiologic (3-5 yrs FU): HRCT scan of chest; Genetic (3-5 yrs FU): Blood sample collection for RNA; 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: Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life; Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT); Radiologic (3-5 yrs FU): HRCT scan of chest; Genetic (3-5 yrs FU): Blood sample collection for RNA; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression of lung disease over time	Radiologic progression of lung disease will be determined through a comparison of baseline HRCT chest findings to follow-up HRCT chest findings at the 3-5 year follow-up benchmark. Similar to baseline, follow-up HRCT scans of the chest will be interpreted by 2 different radiologists. Quantitative radiologic progression will be defined as ≥ 10% increase in fibrotic changes from baseline to follow-up - additionally, the percent reticular change, percent honeycomb change, and percent traction bronchiectasis on the follow-up scan will be quantified and recorded. Radiologic findings of progression will be used in correlation with other clinical features to determine the clinical relevance of the change. The clinical features include - change in cough, change in dyspnea (as measured by UCSD shortness of breath questionnaire), change in FVC percent predicted value, the development of established RA-ILD, or respiratory-related death, over the same time period.	3-5 Years
Impact of subclinical RA-ILD on health-related quality of life in RA	The impact of subclinical RA-ILD on health-related quality of life will be measured using subjective patient questionnaires that will be completed at both baseline and follow-up. These questionnaires include - SF-36, St. George Respiratory Questionnaire, and Multi-Dimensional Health Assessment Questionnaire.	3-5 Years
Outcome of airways disease	Clinical outcomes will be measured through respiratory assessment (physical exam), changes is dyspnea (based on the University of California San Diego shortness of breath questionnaire), changes in FVC percent predicted values (based on pulmonary function testing), increase in cough (determined using a visual analog scale, where 10 is the worst cough and 0 is no cough), and development of RA-ILD requiring treatment.	3-5 Years

Collaborators and Investigators

• Sponsor: University of Colorado, Denver
• Investigators: Principal Investigator: Joyce S Lee, MD, University of Colorado, Denver

Study record dates

Study Major Dates

• Study Start (Actual): June 22, 2017
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027

Study Registration Dates

• First Submitted: September 19, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 29, 2017

Study Record Updates

• Last Update Posted (Actual): November 30, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: Rheumatoid Arthritis; idiopathic pulmonary fibrosis; RA; ILD; lung disease; IPF; Interstitial Lung Disease; connective tissue disease; CTD; airways disease
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid; Lung Diseases; Lung Diseases, Interstitial
• Other Study ID Numbers: 16-1097

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No