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| Tracking Information | |||||||||
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| First Received Date ICMJE | December 19, 2007 | ||||||||
| Last Updated Date | March 31, 2009 | ||||||||
| Start Date ICMJE | October 2007 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00582881 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus | ||||||||
| Official Title ICMJE | Immune Response to Small Nuclear Ribonucleoprotein Autoantigens | ||||||||
| Brief Summary | Systemic lupus erythematosus (SLE) and mixed connective tissue disease (MCTD) are long-term autoimmune diseases in which the immune system attacks parts of the body. The abnormal immune reaction causes inflammation of and damage to various body parts and can affect joints, skin, kidneys, heart, lungs, blood vessels, and the brain. SLE and MCTD often affect young women, especially black and Hispanic women, and there is no known cure. Knowing more about SLE and MCTD will help in developing new and effective treatments. The purpose of this study is to characterize immune system abnormalities, genetic components, and disease progression in people with SLE and MCTD. |
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| Detailed Description | Systemic lupus erythematosus (SLE) is an autoimmune disease in which the immune system produces antibodies against the body's healthy cells and tissues. These antibodies, called autoantibodies, contribute to the inflammation of various parts of the body and can cause damage to organs and tissues. Mixed connective tissue disease (MCTD) is another autoimmune disease that overlaps in terms of signs and symptoms with three other connective tissue diseases, including SLE. In both SLE and MCTD, the immune system appears to be abnormally activated by small nuclear ribonucleoprotein (snRNP) autoantigens. Furthermore, lung tissue, in particular, appears to be affected by the immune response induced by snRNP autoantigens. The causes of SLE and MCTD remain unknown. However, it is likely that a combination of genetic, environmental, and possibly hormonal factors work together to cause the diseases. Past studies suggest that several different genes may be involved in determining a person's likelihood of developing SLE or MCTD, which tissues and organs are affected, and the severity of the disease. The purpose of this study is to characterize immune system abnormalities, genetic components, and disease progression in people with SLE and MCTD. Participants will attend at least four study visits, spaced 3 months apart, over the course of this study. Each study visit will include questionnaires, a physical exam, and possibly blood and/or urine collection. At the end of the study period, participants may choose to continue or discontinue participation. |
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| Study Phase | |||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Cohort, Cross-Sectional | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | |||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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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 | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 400 | ||||||||
| Estimated Completion Date | September 2012 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 16 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00582881 | ||||||||
| Responsible Party | Robert W. Hoffman, University of Miami Miller School of Medicine | ||||||||
| Study ID Numbers ICMJE | R01 AR043308, 2R01 AR 043308-12A1 | ||||||||
| Study Sponsor ICMJE | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) | ||||||||
| Verification Date | March 2009 | ||||||||
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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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