search
Back to results

Specimen Collection for Individuals With Lung Disease Associated With Rheumatoid Arthritis

Primary Purpose

Pulmonary Fibrosis, Rheumatoid Arthritis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Pulmonary Fibrosis focused on measuring Bronchoscopy, Idiopathic Pulmonary Fibrosis, Proteases, Fibroblast Proliferation, Reactive Proteins, Rheumatoid Arthritis, Pulmonary Fibrosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Boston University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
November 3, 1999
Last Updated
June 30, 2017
Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00001884
Brief Title
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

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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Fibrosis, Rheumatoid Arthritis
Keywords
Bronchoscopy, Idiopathic Pulmonary Fibrosis, Proteases, Fibroblast Proliferation, Reactive Proteins, Rheumatoid Arthritis, Pulmonary Fibrosis

7. Study Design

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy 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.
Facility Information:
Facility Name
Boston University
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118-2354
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
3487321
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.
Results Reference
background

Learn more about this trial

Specimen Collection for Individuals With Lung Disease Associated With Rheumatoid Arthritis

We'll reach out to this number within 24 hrs