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Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease (RAPID)

This study is currently recruiting participants.
Verified September 2017 by University of Colorado, Denver
Sponsor:
ClinicalTrials.gov Identifier:
NCT03297775
First Posted: September 29, 2017
Last Update Posted: September 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Colorado, Denver
  Purpose

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
Rheumatoid Arthritis Interstitial Lung Disease

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Rheumatoid Arthritis Patients at Risk for Interstitial Lung Disease

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 500
Actual Study Start Date: June 22, 2017
Estimated Study Completion Date: June 2027
Estimated Primary Completion Date: June 2027 (Final data collection date for primary outcome measure)
Groups/Cohorts
Evidence of interstitial lung disease

Subjects who screen positive for ILD will be followed annually until study closure.

Assessments are as follows:

  1. Clinical - Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment)
  2. Physiologic - Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance
  3. Radiologic - Assessment for airways disease, interstitial lung abnormalities
  4. Genetic - DNA, RNA
  5. Biologic - Serum, Plasma, Sputum
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:

  1. Clinical - Demographics (e.g., age, sex, self-reported race, etc.), Health related behaviors, including smoking history, Co-morbidities and medications, Respiratory symptom assessment (e.g., cough, dyspnea), Rheumatologic assessment (e.g., disease duration, disease severity, treatment)
  2. Physiologic - Forced vital capacity (FVC), diffusing capacity for carbon monoxide (DLCO), 6-minute walk distance
  3. Radiologic - Assessment for airways disease, interstitial lung abnormalities
  4. Genetic - DNA, RNA
  5. Biologic - Serum, Plasma, Sputum

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects are selected for participation in the study because they have an active diagnosis of rheumatoid arthritis and are at risk fro the development of lung disease.
Criteria

Inclusion Criteria:

  • Diagnosis of RA using the 2010 American College of Rheumatology (ACR) criteria

Exclusion Criteria:

  • Inability to give informed consent
  • Pregnant women
  • History of Interstitial Lung Disease
  • Evidence of other cause of diffuse parenchymal lung disease such as infection, drug toxicity, other autoimmune processes, etc.
  Contacts and Locations
Information from the National Library of Medicine

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


Contacts
Contact: Lina Stanchev, MS 303-724-9469 LINA.STANCHEV@UCDENVER.EDU
Contact: Joyce S Lee, MD 303-724-6109 joyce.lee@ucdenver.edu

Locations
United States, Colorado
University of Colorado - Anschutz Medical Campus Recruiting
Aurora, Colorado, United States, 80045
Contact: Lina Stanchev, MS    303-724-9469    lina.stanchev@ucdenver.edu   
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         
Sponsors and Collaborators
University of Colorado, Denver
Investigators
Principal Investigator: Joyce S Lee, MD University of Colorado, Denver
  More Information

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT03297775     History of Changes
Other Study ID Numbers: 16-1097
First Submitted: September 19, 2017
First Posted: September 29, 2017
Last Update Posted: September 29, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University of Colorado, Denver:
Rheumatoid Arthritis
RA
Interstitial Lung Disease
ILD
lung disease
connective tissue disease
CTD
idiopathic pulmonary fibrosis
IPF
airways disease

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Lung Diseases
Lung Diseases, Interstitial
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Respiratory Tract Diseases