Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis

NCT ID: NCT00001885

Last Updated: 2017-07-02

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

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

1999-03-21

Study Completion Date

2007-12-28

Brief Summary

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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

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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.

Conditions

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Healthy Pulmonary Fibrosis Rheumatoid Arthritis

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role lead

Locations

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National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 3335140 (View on PubMed)

Other Identifiers

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99-H-0069

Identifier Type: -

Identifier Source: secondary_id

990069

Identifier Type: -

Identifier Source: org_study_id

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