Clinical trial NCT00001884: Specimen Collection for Individuals With Lung Disease Associated With Rheumatoid Arthritis
Official title: Specimen Procurement for Individuals With Pulmonary Fibrosis Associated With Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Fibrosis
Rheumatoid Arthritis
Keywords: Bronchoscopy
Idiopathic Pulmonary Fibrosis
Proteases
Fibroblast Proliferation
Reactive Proteins
Rheumatoid Arthritis
Pulmonary Fibrosis
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes

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.

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: 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.

Eligibility criteria: * 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston University
state: Massachusetts
Study officials:
References:
citation: 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.