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Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

NCT ID: NCT03297775

Last Updated: 2023-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

750 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-06-22

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis Interstitial Lung Disease

Keywords

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Rheumatoid Arthritis RA Interstitial Lung Disease ILD lung disease connective tissue disease CTD idiopathic pulmonary fibrosis IPF airways disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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RA with Sub-clinical ILD

Subjects will be followed annually until study closure.

Assessments are as follows:

1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life
2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT)
3. Radiologic (3-5 yrs FU): HRCT scan of chest
4. Genetic (3-5 yrs FU): Blood sample collection for RNA
5. Biologic (3-5 yrs FU): Blood sample collection for other blood markers

No interventions assigned to this group

RA with No-ILD

Subjects will be followed annually until study closure.

Assessments are as follows:

1. Clinical (Annual): Demographics, health-related behaviors, co-morbidities, medications, respiratory symptoms, rheumatologic assessment, quality of life
2. Physiologic (3-5 yrs FU): Lung function on Pulmonary Function Test (PFT)
3. Radiologic (3-5 yrs FU): HRCT scan of chest
4. Genetic (3-5 yrs FU): Blood sample collection for RNA
5. 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.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Colorado, Denver

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joyce S Lee, MD

Role: PRINCIPAL_INVESTIGATOR

University of Colorado, Denver

Locations

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University of Colorado - Anschutz Medical Campus

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Haylie A Lengel

Role: CONTACT

Phone: 970-376-8303

Email: [email protected]

Joyce S Lee, MD

Role: CONTACT

Phone: 303-724-6109

Email: [email protected]

Facility Contacts

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Haylie A Lengel

Role: primary

Elizabeth O'Brien

Role: backup

Other Identifiers

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16-1097

Identifier Type: -

Identifier Source: org_study_id