Defining the Molecular and Radiologic Phenotype of Progressive RA Interstitial Lung Disease

Purpose

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.

Conditions

  • Rheumatoid Arthritis
  • Interstitial Lung Disease

Eligibility

Eligible Ages
Between 18 Years and 90 Years
Eligible Genders
All
Accepts 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

Study Design

Phase
Study Type
Observational [Patient Registry]
Observational Model
Cohort
Time Perspective
Prospective

Arm Groups

ArmDescriptionAssigned Intervention
Patients with RA-ILD Assessments include: - Clinical: height, weight, oxygen saturation at rest, and 6-minute walk test. - Rheumatological: study Rheumatologist will document rheumatoid arthritis symptoms and clinical findings at baseline and follow-up. - Pulmonary Function Testing: data will be collected from clinically performed spirometry and diffusing capacity for carbon monoxide. - High-resolution computed tomography (HRCT) imaging: HRCT scans will be collected at baseline and 12 months in line with standard of care for treatment of RA-ILD. - Lab specimens: peripheral blood will be obtained for DNA, RNA, serum, and plasma at baseline and at 12 months for all sites or every 3-4 months in Colorado. Buccal swabs (cheek) will also be collected once each year. - Information collected: will include demographics, co-morbidities, disease history, medication history, pulmonary function, radiographic imaging, and transplant/survival status through questionnaires and medical chart review.
  • Genetic: Research Testing Performed (Laboratory)
    Blood collection (DNA, RNA)
  • Diagnostic Test: Information Collected as Standard of Care
    High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)
  • Other: Research Testing Performed
    Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires

Recruiting Locations

University of Kansas
Kansas City, Kansas 66103
Contact:
Scott Matson, MD

More Details

Status
Recruiting
Sponsor
University of Colorado, Denver

Study Contact

Haylie Lengel
970-376-8303
haylie.lengel@cuanschutz.edu

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