Specimen Collection for Individuals With Lung Disease Associated With Rheumatoid Arthritis

NCT ID: NCT00001884

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

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.

Researchers hope to improve their understanding of the disease process involved in PF and RA by analyzing specimens collected by bronchoscopy, lung biopsy, lung transplantation, or autopsy from patients with these conditions.

The purpose of this study is to collect specimens from rheumatoid arthritis patients with and without pulmonary fibrosis as well as patients with pulmonary fibrosis without associated diseases or cause (idiopathic pulmonary fibrosis).

Detailed Description

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The etiology of pulmonary fibrosis in individuals with rheumatoid arthritis is unknown. Analysis of blood and specimens procured by bronchoscopy, lung biopsy, lung transplantation, or post-mortem examination from patients with this disorder will contribute to our understanding of the pathogenetic mechanisms of pulmonary fibrosis in rheumatoid arthritis. The purpose of this protocol is to obtain blood and specimens by bronchoscopy, lung biopsy, lung transplantation, or post-mortem examination from rheumatoid arthritis patients with and without pulmonary fibrosis, individuals with idiopathic pulmonary fibrosis, and healthy research volunteers.

Conditions

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Pulmonary Fibrosis Rheumatoid Arthritis

Eligibility Criteria

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Inclusion Criteria

Non-smokers (never smoked or not smoked within the previous 2 years) who are 18 years of age or older with any of the following:

RA with PF (biopsy-proven), or

RA-only, or

Idiopathic PF-only (biopsy-proven), or

Healthy research volunteers by history and indicated tests (individuals without history of chronic cardiopulmonary disorder, collagen vascular disease, or bleeding disorder) matched for age (within 5 years) and gender.

Exclusion Criteria

Individuals with any of the following:

Forced expiratory volume in one second (FEV(1)) less than 1L.

Inhalational exposure to fibrogenic fibers or dusts (i.e., asbestos, silica, coal, beryllium).

Chronic cardiopulmonary disorders other than pulmonary fibrosis.

Other collagen vascular disorders (i.e., systemic lupus erythematosus, scleroderma, polymyositis, mixed connective tissue disease).

Non-rheumatoid arthritis.

Viral infections associated with PF (i.e., hepatitis B, hepatitis C, human immunodeficiency virus).

Uncorrectable bleeding diathesis.

Pregnancy or lactation.
Minimum Eligible Age

18 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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Boston University

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Michalski JP, McCombs CC, Scopelitis E, Biundo JJ Jr, Medsger TA Jr. Alpha 1-antitrypsin phenotypes, including M subtypes, in pulmonary disease associated with rheumatoid arthritis and systemic sclerosis. Arthritis Rheum. 1986 May;29(5):586-91. doi: 10.1002/art.1780290502.

Reference Type BACKGROUND
PMID: 3487321 (View on PubMed)

Other Identifiers

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99-H-0068

Identifier Type: -

Identifier Source: secondary_id

990068

Identifier Type: -

Identifier Source: org_study_id

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