An observational study in Rheumatoid Arthritis and Interstitial Lung Disease, sponsored by University of Colorado, Denver. Recruiting at 1 site in United States. Open to participants aged 45 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-05-01.
Sponsored by University of Colorado, Denver · Observational
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.
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.
Exclusion Criteria:
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
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.
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.
Time frame: 3-5 years
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.
Time frame: 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.
Time frame: 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.
Time frame: 3-5 Years
Plan to share: No
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University of Colorado, Denver