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Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

Study Purpose

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.

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 45 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

1. ≥ 45years old. 2. Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria.

Exclusion Criteria:

1. Inability to give informed consent. 2. Pregnant women. 3. History of interstitial lung disease. 4. Evidence of other causes of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc. 5. Subjects over the age of 90 years old or less than 45 years old

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.

 NCT03297775
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, MD
Principal Investigator Affiliation University of Colorado, Denver
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Rheumatoid Arthritis, Interstitial Lung Disease
Arms & Interventions

Arms

: RA with Sub-clinical ILD

Subjects will be followed annually until study closure. Assessments are as follows: Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) Radiologic (3-5 yrs FU): HRCT scan of chest Genetic (3-5 yrs FU): Blood sample collection for RNA Biologic (3-5 yrs FU): Blood sample collection for other blood markers

: RA with No-ILD

Subjects will be followed annually until study closure. Assessments are as follows: Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT) Radiologic (3-5 yrs FU): HRCT scan of chest Genetic (3-5 yrs FU): Blood sample collection for RNA Biologic (3-5 yrs FU): Blood sample collection for other blood markers Note: Certain follow-up procedures may not occur for every subject and will be determined by the research team.

Interventions

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.

Aurora, Colorado

Status

Recruiting

Address

University of Colorado - Anschutz Medical Campus

Aurora, Colorado, 80045

Site Contact

Haylie A Lengel

haylie.lengel@cuanschutz.edu

970-376-8303

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