Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus
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| ClinicalTrials.gov Identifier: NCT00582881 |
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Recruitment Status :
Recruiting
First Posted : December 28, 2007
Last Update Posted : March 17, 2023
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| Condition or disease |
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| Mixed Connective Tissue Disease (MCTD) Systemic Lupus Erythematosus (SLE) |
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 up to four study visits, at intervals of at least 3 months, 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.
| Study Type : | Observational |
| Estimated Enrollment : | 400 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Immune Response to Small Nuclear Ribonucleoprotein Autoantigens |
| Actual Study Start Date : | October 2007 |
| Estimated Primary Completion Date : | September 2027 |
| Estimated Study Completion Date : | September 2029 |
- Data characterizing immune cell responses and corresponding clinical data [ Time Frame: Up to 4 visits at intervals of at least 3 months. ]
- Phenotype measurement to include disease activity, disease severity, and functional status [ Time Frame: up to 4 visits at intervals of at least 3 months ]
Biospecimen Retention: Samples With DNA
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Patients with known rheumatic diseases including systemic lupus erythematosus, rheumatoid arthritis, connective tissue disease, undifferentiated connective tissue disease
Exclusion Criteria:
- Poor venous access, unstable medical problems or significant cardiopulmonary disease, anemia, leukopenia, thrombocytopenia, anticoagulation therapy, recent significant changes in medication or pregnacy. Patient cannot be taking large dose of corticosteroids (above 30mg per day) or cytotoxic drugs (cyclophosphamide, azathiprine, cyclosporine, methotrexate).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00582881
| Contact: Bethly Aubourg, MD | 305-243-8567 | baubourg@med.miami.edu | |
| Contact: Eric L. Greidinger, MD | 305-243-8913 | egreidinger@med.miami.edu |
| United States, Florida | |
| University of Miami Miller School of Medicine | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Bethly Aubourg, MD 305-243-8567 baubourg@med.miami.edu | |
| Principal Investigator: | Eric L. Greidinger, MD | University of Miami |
| Responsible Party: | Eric L. Greidinger, Associate Professor of Medicine, University of Miami |
| ClinicalTrials.gov Identifier: | NCT00582881 |
| Other Study ID Numbers: |
20030724 5R01AR043308-16 ( U.S. NIH Grant/Contract ) 5R01AR043308-14 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 28, 2007 Key Record Dates |
| Last Update Posted: | March 17, 2023 |
| Last Verified: | March 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Anti-RNP/Sm Autoantibody-Positive MCTD SLE |
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Lupus Erythematosus, Systemic Connective Tissue Diseases Mixed Connective Tissue Disease Autoimmune Diseases Immune System Diseases |