Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis

• Sponsor: National Heart, Lung, and Blood Institute (NHLBI) (NIH)
• Overall Status: Completed
• CT.gov ID: NCT00001885
• Collaborator: (none)
• Enrollment: 400
• Location: 1
• Duration (Months): 105.3
• Patients Per Site Per Month: 3.8

Study Details

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.

Data gathered from previous research studies suggest that genetics may play a role in the development of PF in patients with rheumatoid arthritis. However, the actual genetic factors involved in the disease process have not been identified.

The goal of this study is to identify the genetic markers in patients with pulmonary fibrosis and rheumatoid arthritis.

Condition or Disease	Intervention/Treatment	Phase
Healthy; Pulmonary Fibrosis; Rheumatoid Arthritis

Detailed Description

Pulmonary fibrosis that develops within a subpopulation of patients with rheumatoid arthritis is a disorder of unknown etiology. Although previous reports suggest that some individuals with rheumatoid arthritis have a genetic predisposition to the development of fibrotic lung disease, genetic factors have not been clearly identified. It is the intent of this clinical protocol to identify genetic polymorphisms in individuals with pulmonary fibrosis and rheumatoid arthritis.

Study Design

• Study Type: Observational
• Official Title: Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Identification of Genetic Polymorphisms
• Study Start Date: Mar 21, 1999
• Study Completion Date: Dec 28, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

• Ages Eligible for Study: 21 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

• INCLUSION CRITERIA:

Individuals 21 years of age or older with any of the following:

RA (based on 1987 American College of Rheumatology Revised Criteria for the Classification of RA) with PF (biopsy-proven), or

RA-only, or

Biopsy-proven idiopathic PF-only, or

Healthy research volunteers.

EXCLUSION CRITERIA:

Individuals with any of the following:

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

Chronic pulmonary 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 PF (e.g., hepatitis B, hepatitis C, human immunodeficiency virus).

Pregnancy.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland	United States	20892

Sponsors and Collaborators

• National Heart, Lung, and Blood Institute (NHLBI)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Hakala M. Poor prognosis in patients with rheumatoid arthritis hospitalized for interstitial lung fibrosis. Chest. 1988 Jan;93(1):114-8.

• ClinicalTrials.gov Identifier: NCT00001885
• Other Study ID Numbers: 990069; 99-H-0069
• First Posted: Nov 4, 1999
• Last Update Posted: Jul 2, 2017
• Last Verified: Dec 28, 2007

• Keywords provided by , ,: Interstitial Lung Disease; Inherited Disease; Genetic Markers; Alpha 1 Protease Inhibitor; DNA Mutations; Rheumatoid Arthritis; Pulmonary Fibrosis; Normal Volunteer
• Additional relevant MeSH terms: Arthritis; Arthritis, Rheumatoid; Pulmonary Fibrosis; Fibrosis

Study Results

No Results Posted as of Jul 2, 2017