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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RA with Sub-clinical ILD | Subjects will be followed annually until study closure. Assessments are as follows:
| ||
| RA with No-ILD | Subjects will be followed annually until study closure. Assessments are as follows:
Note: Certain follow-up procedures may not occur for every subject and will be determined by the research team. |
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| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Haylie A Lengel | Contact | 970-376-8303 | haylie.lengel@cuanschutz.edu | |
| Joyce S Lee, MD | Contact | 303-724-6109 | joyce.lee@ucdenver.edu |
| Name | Affiliation | Role |
|---|---|---|
| Joyce S Lee, MD | University of Colorado, Denver | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Colorado - Anschutz Medical Campus | Recruiting | Aurora | Colorado | 80045 | United States |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D003240 | Connective Tissue Diseases |
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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The following bio-specimens will be collected at baseline and at 3-5 years follow-up:
| 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D012140 | Respiratory Tract Diseases |
| D011658 | Pulmonary Fibrosis |