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| Tracking Information | |
|---|---|
| First Received Date ICMJE | November 3, 1999 |
| Last Updated Date | March 5, 2008 |
| Start Date ICMJE | March 1999 |
| Primary Completion Date | |
| Current Primary Outcome Measures ICMJE | |
| Original Primary Outcome Measures ICMJE | |
| Change History | Complete list of historical versions of study NCT00001885 on ClinicalTrials.gov Archive Site |
| Current Secondary Outcome Measures ICMJE | |
| Original Secondary Outcome Measures ICMJE | |
| Descriptive Information | |
| Brief Title ICMJE | Identification of Genes Associated With Lung Disease in Patients With Rheumatoid Arthritis |
| Official Title ICMJE | Pulmonary Fibrosis Associated With Rheumatoid Arthritis: Identification of Genetic Polymorphisms |
| 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. |
| 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 Phase | |
| Study Type ICMJE | Observational |
| Study Design ICMJE | |
| Condition ICMJE |
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| Intervention ICMJE | |
| Study Arms / Comparison Groups | |
| Publications * | Hakala M. Poor prognosis in patients with rheumatoid arthritis hospitalized for interstitial lung fibrosis. Chest. 1988 Jan;93(1):114-8. |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |
| Recruitment Status ICMJE | Completed |
| Enrollment ICMJE | 400 |
| Completion Date | December 2007 |
| Primary Completion Date | |
| Eligibility Criteria ICMJE |
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. |
| Gender | Both |
| Ages | 21 Years and older |
| Accepts Healthy Volunteers | Yes |
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects |
| Location Countries ICMJE | United States |
| Administrative Information | |
| NCT ID ICMJE | NCT00001885 |
| Responsible Party | |
| Study ID Numbers ICMJE | 990069, 99-H-0069 |
| Study Sponsor ICMJE | National Heart, Lung, and Blood Institute (NHLBI) |
| Collaborators ICMJE | |
| Investigators ICMJE | |
| Information Provided By | National Institutes of Health Clinical Center (CC) |
| Verification Date | December 2007 |
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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