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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00582881
Other study ID # 20030724
Secondary ID 5R01AR043308-165
Status Recruiting
Phase
First received
Last updated
Start date October 2007
Est. completion date September 2029

Study information

Verified date February 2024
Source University of Miami
Contact Bethly Aubourg, MD
Phone 305-243-8567
Email baubourg@med.miami.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date September 2029
Est. primary completion date September 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years to 100 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Miami Miller School of Medicine Miami Florida

Sponsors (2)

Lead Sponsor Collaborator
University of Miami National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Data characterizing immune cell responses and corresponding clinical data Up to 4 visits at intervals of at least 3 months.
Primary Phenotype measurement to include disease activity, disease severity, and functional status up to 4 visits at intervals of at least 3 months
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