Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)
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|ClinicalTrials.gov Identifier: NCT03297775|
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : October 2, 2018
The overall goal of this study is to define the phenotype of Interstitial Lung Disease (ILD) in patients with rheumatoid arthritis (RA). The investigators hypothesize that there are common elements between other forms of ILD such as idiopathic pulmonary fibrosis (IPF) and sub-clinical RA-ILD that places individuals at risk for the development of lung disease.
This is not a treatment study. It is a protocol designed to enroll individuals affected by RA and explore associated lung disease so that the investigators can better understand the clinical phenotype and genetic and molecular endotypes of this disease.
|Condition or disease|
|Rheumatoid Arthritis Interstitial Lung Disease|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease|
|Actual Study Start Date :||June 22, 2017|
|Estimated Primary Completion Date :||June 2027|
|Estimated Study Completion Date :||June 2027|
Evidence of interstitial lung disease
Subjects who screen positive for ILD will be followed annually until study closure.
Assessments are as follows:
No evidence of interstitial lung disease
Subjects who screen negative for ILD will be followed five years after the initial screen and re-screened with a chest CT scan to check for evidence of new lung disease.
Assessments are as follows:
- Presence or absence of interstitial lung disease on high resolution CT (HRCT) imaging [ Time Frame: 10 years ]This study is designed to evaluate individuals affected by RA and explore associated lung disease so that the investigators can better understand the clinical phenotype and genetic and molecular endotypes of this disease.
Biospecimen Retention: Samples With DNA
Depending on which one of the two cohorts subjects are assigned the following biospecimens will be collected either yearly or every five years:
DNA, RNA, Serum, Plasma, Sputum
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297775
|Contact: Lina Stanchev, MS||303-724-9469||LINA.STANCHEV@UCDENVER.EDU|
|Contact: Joyce S Lee, MDfirstname.lastname@example.org|
|United States, Colorado|
|University of Colorado - Anschutz Medical Campus||Recruiting|
|Aurora, Colorado, United States, 80045|
|Contact: Lina Stanchev, MS 303-724-9469 email@example.com|
|Principal Investigator: Joce Lee, MD|
|Sub-Investigator: Kristen Demoruelle, MD|
|Sub-Investigator: Aryeh Fischer, MD|
|Sub-Investigator: Jason Kolfenbach, MD|
|Sub-Investigator: Duane Pearson, MD|
|Sub-Investigator: Kevin Deane, MD|
|Principal Investigator:||Joyce S Lee, MD||University of Colorado, Denver|