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

Study 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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	18 Years - 90 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06397677
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	University of Colorado, Denver
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Joyce S Lee
Principal Investigator Affiliation	University of Colorado, Denver
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other, NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Rheumatoid Arthritis, Interstitial Lung Disease

Additional Details

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

Arms & Interventions

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

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

University of California San Francisco, San Francisco, California

Status

Recruiting

Address

University of California San Francisco

San Francisco, California, 94143

Site Contact

Paul Wolters, MD

[email protected]

970-376-8303

University of Colorado Denver, Aurora, Colorado

Status