Lung Disease Associated With Rheumatoid Arthritis

Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Definition of the Natural History of Disease

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00001876

Enrollment

132

Registered

1999-11-04

Start date

1999-04-05

Completion date

2007-12-11

Last updated

2022-09-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Fibrosis

Keywords

Interstitial Lung Disease, Collagen Vascular Disease, Extracellular Matrix, Pulmonary Function, DTPA Lung Clearance Scan, Natural History

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. Patients participating in this study will undergo a series of tests and examinations before and throughout the study. The tests include blood and urine tests, electrical measures of heart function (ECG), chest x-rays, CAT scans, nuclear medicine scans, breathing tests, exercise tests, and fiberoptic bronchoscopy. The goals of this study are to: 1. Estimate how common pulmonary fibrosis is in patients with rheumatoid arthritis, 2. Describe the natural course of pulmonary fibrosis in patients with rheumatoid arthritis, 3. Estimate the survival rate of patients with pulmonary fibrosis and rheumatoid arthritis, and 4. Learn more about the factors that contribute to the development or progression fibrotic lung disease....

Detailed description

Pulmonary fibrosis is an extra-articular manifestation of rheumatoid arthritis whose etiology remains uncertain. Although the clinical course of many individuals with this disorder can mimic that observed in patients with idiopathic pulmonary fibrosis, the natural history of fibrotic lung disease associated with rheumatoid arthritis remains largely undefined. It is the intent of this clinical protocol to (1) estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis, (2) define the natural history of pulmonary fibrosis in patients with rheumatoid arthritis, (3) estimate the survival rate of individuals with pulmonary fibrosis and rheumatoid arthritis, and (4) examine pulmonary physiologic, radiologic, and biochemical markers that predict the development or progression of fibrotic lung disease.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

Inclusion criteria

* INCLUSION CRITERIA: Non-smokers (never smoked or no smoking within the previous 2 years) who are 21 years of age or older with any of the following: Rheumatoid arthritis with biopsy-proven pulmonary fibrosis or; Rheumatoid arthritis only, or; Biopsy-proven idiopathic pulmonary fibrosis.

Exclusion criteria

Forced expiratory volume in one second (FEV1) less than 1L. Inhalational exposure to fibrogenic fibers or dusts (e.g., asbestos, silica, coal, beryllium). Chronic cardiopulmonary 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 pulmonary fibrosis (e.g., hepatitis B, hepatitis C, human immunodeficiency virus). Uncorrectable bleeding diathesis. Pregnancy or lactation.

Design outcomes

Primary

Measure	Time frame	Description
Prevalence	Ongoing	To estimate the prevalence of pulmonary fibrosis in individuals with rheumatoid arthritis. Subjects will include patients that have rheumatoid arthritis-only.
Natural History	Ongoing	To define the natural history of pulmonary fibrosis associated with rheumatoid arthritis in a prospective, longitudinal study.

Countries

United States

Outcome results