Interstitial Lung Disease, Rheumatoid Arthritis
Conditions
Brief summary
A study to identify patients with Rheumatoid Arthritis - Associated Interstitial Lung Disease (RA-ILD) that are at the highest risk for progression. The goal of the investigators is to recruit a group of patients with RA-ILD and collect information to help us understand more about disease progression. The investigators will do this using a combination of clinical, radiologic, and biologic features.
Detailed description
The central hypothesis is that novel quantitative imaging and specific blood markers will be associated with progressive RA-ILD. The hypothesis will be tested through collection and analysis of peripheral blood, in addition to the analysis of HRCT (high-resolution computed tomography) scans performed as standard of care (clinical) on research subjects. Procedures performed: Baseline Year 0: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs Every 4 months (at clinic visit): Blood sample, questionnaires Year 1 and Year 2 Follow-ups: Blood sample, buccal (cheek) swab, questionnaires and if performed clinically - Pulmonary Function tests, 6 Minute Walk Test, and HRCT scan of lungs
Interventions
GENETICResearch Testing Performed (Laboratory)
Blood collection (DNA, RNA)
DIAGNOSTIC_TESTInformation Collected as Standard of Care
High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)
OTHERResearch Testing Performed
Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
University of California, San Francisco
University of Michigan
University of Kansas
University of Colorado, Denver
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Multidisciplinary diagnosis of RA-ILD based on the 2010 American College of Rheumatology criteria * 18 years of age or older
Exclusion criteria
* Prior medication treatment specifically for RA-ILD * Inability to give informed consent * Pregnant women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluating the role of novel quantitative imaging | 5-years | Through evaluation of baseline CT scans and application of novel quantitative technology, investigators will monitor for specific patterning to identify patients at risk for progression. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Comparing peripheral blood telomere length (PB-TL) | 5-years | Investigators will test and validate if baseline peripheral blood telomere length (PB-TL) predicts a progressive phenotype in RA-ILD. |
| Defining peripheral blood transcriptomic profiles | 5-years | Investigators will define and validate the peripheral blood transcriptomic profile of progressive RA-ILD. |
| Exploring if a composite profile more accurately identifies progressive RA-ILD | 5-years | Investigators will use logistic least absolute shrinkage and selection operator (LASSO) to develop a predictive model of RA-ILD progression using demographics, novel imaging, PB-TL and peripheral blood transcriptome. |
Countries
United States
Contacts
Primary ContactHaylie Lengel
Backup ContactJoyce S Lee
Outcome results
None listed