Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus

Systemic Lupus Erythematosus (SLE) Clinical Trial

Official title:

Immune Response to Small Nuclear Ribonucleoprotein Autoantigens

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00582881
• Other study ID #: 20030724
• Secondary ID: 5R01AR043308-165
• Status: Recruiting
• 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
• 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).

Related Conditions & MeSH terms

• Connective Tissue Diseases
• Lupus Erythematosus, Systemic
• Mixed Connective Tissue Disease
• Mixed Connective Tissue Disease (MCTD)
• Systemic Lupus Erythematosus (SLE)

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