Bethesda, Maryland 20892

  • Pulmonary Fibrosis

Purpose:

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.


Study summary:

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.


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.


Study is Available At:


Original ID:

990056


NCT ID:

NCT00001876


Secondary ID:

99-HG-0056


Study Acronym:


Brief Title:

Lung Disease Associated With Rheumatoid Arthritis


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

21 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

National Institutes of Health Clinical Center (CC)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

3


Total Enrollment:

132


Enrollment Type:

Actual


Overall Contact Information

Official Name:Bernadette R Gochuico, M.D.
Principal Investigator
National Human Genome Research Institute (NHGRI)

Study Dates

Start Date:April 5, 1999
Verification Date:February 25, 2021
Last Changed Date:May 19, 2021
First Received Date:November 3, 1999

Study Outcomes

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

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:rheumatoid arthritis
Description:Patients with rheumatoid arthritis only.
Study Arm Type:Other
Arm Name:pulmonary fibrosis
Description:Patients with biobsy-proven idiopathic pulmonary fibrosis only.
Study Arm Type:Other
Arm Name:Combo
Description:Patients with rheumatoid arthritis and biopsy-proven pulmonary fibrosis.

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Human Genome Research Institute (NHGRI)
Agency Class:NIH
Agency Type:Collaborator
Agency Name:National Heart, Lung, and Blood Institute (NHLBI)

Samples and Retentions

Study Population: Subjects will include individuals with (1) rheumatoid arthritis and biopsy-proven pulmonary fibrosis, (2) rheumatoid arthritis-only, and (3) biopsy-proven idiopathic pulmonary fibrosis-only.@@@
Sample Method:Non-Probability Sample

Study References

Reference Type:Reference
Citation:Saag KG, Kolluri S, Koehnke RK, Georgou TA, Rachow JW, Hunninghake GW, Schwartz DA. Rheumatoid arthritis lung disease. Determinants of radiographic and physiologic abnormalities. Arthritis Rheum. 1996 Oct;39(10):1711-9.
PMID:8843862
Reference Type:Reference
Citation:Anaya JM, Diethelm L, Ortiz LA, Gutierrez M, Citera G, Welsh RA, Espinoza LR. Pulmonary involvement in rheumatoid arthritis. Semin Arthritis Rheum. 1995 Feb;24(4):242-54. Review.
PMID:7740304
Reference Type:Reference
Citation:Roschmann RA, Rothenberg RJ. Pulmonary fibrosis in rheumatoid arthritis: a review of clinical features and therapy. Semin Arthritis Rheum. 1987 Feb;16(3):174-85. Review.
PMID:3547656

Data Source: ClinicalTrials.gov

Date Processed: July 27, 2021

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