Back to resultsIdentification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis
Primary Purpose
Healthy, Pulmonary Fibrosis, Rheumatoid Arthritis
Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
About this trial
This is an observational trial for Healthy focused on measuring Interstitial Lung Disease, Inherited Disease, Genetic Markers, Alpha 1 Protease Inhibitor, DNA Mutations, Rheumatoid Arthritis, Pulmonary Fibrosis, Normal Volunteer
Eligibility Criteria
INCLUSION CRITERIA: Individuals 21 years of age or older with any of the following: RA (based on 1987 American College of Rheumatology Revised Criteria for the Classification of RA) with PF (biopsy-proven), or RA-only, or Biopsy-proven idiopathic PF-only, or Healthy research volunteers. EXCLUSION CRITERIA: Individuals with any of the following: Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium). Chronic pulmonary disorders other than pulmonary fibrosis. Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease). Non-rheumatoid arthritis. Viral infections associated with PF (e.g., hepatitis B, hepatitis C, human immunodeficiency virus). Pregnancy.
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00001885
First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT00001885
Brief Title
Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis
Official Title
Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Identification of Genetic Polymorphisms
Study Type
Observational
2. Study Status
Record Verification Date
December 28, 2007
Overall Recruitment Status
Completed
Study Start Date
March 21, 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 28, 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
5. Study Description
Brief Summary
Pulmonary fibrosis (PF) is a condition in which the lungs of a patient become scarred and fibrous. It has been known to occur in as many as 40% of patients diagnosed with rheumatoid arthritis (RA). The cause of the pulmonary fibrosis in patients with RA is unknown.
Data gathered from previous research studies suggest that genetics may play a role in the development of PF in patients with rheumatoid arthritis. However, the actual genetic factors involved in the disease process have not been identified.
The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis and rheumatoid arthritis.
Detailed Description
Pulmonary fibrosis that develops within a subpopulation of patients with rheumatoid arthritis is a disorder of unknown etiology. Although previous reports suggest that some individuals with rheumatoid arthritis have a genetic predisposition to the development of fibrotic lung disease, genetic factors have not been clearly identified. It is the intent of this clinical protocol to identify genetic polymorphisms in individuals with pulmonary fibrosis and rheumatoid arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Pulmonary Fibrosis, Rheumatoid Arthritis
Keywords
Interstitial Lung Disease, Inherited Disease, Genetic Markers, Alpha 1 Protease Inhibitor, DNA Mutations, Rheumatoid Arthritis, Pulmonary Fibrosis, Normal Volunteer
7. Study Design
Enrollment
400 (false)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA:
Individuals 21 years of age or older with any of the following:
RA (based on 1987 American College of Rheumatology Revised Criteria for the Classification of RA) with PF (biopsy-proven), or
RA-only, or
Biopsy-proven idiopathic PF-only, or
Healthy research volunteers.
EXCLUSION CRITERIA:
Individuals with any of the following:
Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium).
Chronic pulmonary disorders other than pulmonary fibrosis.
Other collagen vascular disorders (e.g., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).
Non-rheumatoid arthritis.
Viral infections associated with PF (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).
Pregnancy.
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
3335140
Citation
Hakala M. Poor prognosis in patients with rheumatoid arthritis hospitalized for interstitial lung fibrosis. Chest. 1988 Jan;93(1):114-8. doi: 10.1378/chest.93.1.114.
Results Reference
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Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis
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