Recruiting

Observational Study

Sponsor:

University of Colorado, Denver

Code:

NCT06397677

Conditions

Rheumatoid Arthritis

Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Research Testing Performed (Laboratory)

Information Collected as Standard of Care

Research Testing Performed

Study Details

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.

Conditions

Rheumatoid Arthritis

Interstitial Lung Disease

Study ID

NCT06397677

Start date

Jan 22, 2024

Status verified date

Apr, 2024

Completion date

Jan, 2034

Anticipated

Primary completion date

Jan, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

450 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Research Testing Performed (Laboratory)

Blood collection (DNA, RNA)

Information Collected as Standard of Care

High Resolution CT Scan (Chest), Pulmonary Function Testing (PFT), 6-Minute Walk Test (6MWT)

Research Testing Performed

Blood collection (non-genetic), Buccal Swab, Rheumatologic Assessment, Pulmonary Assessment, Questionnaires

Primary outcome measure

  • Evaluating the role of novel quantitative imaging [ Time Frame: 5-years ]

Central Contacts and Locations

Central contacts

Haylie Lengel

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

Joyce S Lee

303-724-6109joyce.lee@cuanschutz.edu

Locations

University of California San Francisco

Recruiting

San Francisco, California, United States, 94143

University of Colorado Denver

Recruiting

Aurora, Colorado, United States, 80045

Contacts

Haylie A Lengel

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

Principal Investigator:

Joyce S Lee, MD

University of Kansas

Recruiting

Kansas City, Kansas, United States, 66103

University of Michigan

Recruiting

Ann Arbor, Michigan, United States, 48109

More Information

Sponsor

University of Colorado, Denver

Last update posted

May 3, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Colorado, Denver on 2024-05-03.