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

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ClinicalTrials.gov Identifier: NCT00582881
Recruitment Status : Recruiting
First Posted : December 28, 2007
Last Update Posted : March 17, 2023
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Eric L. Greidinger, University of Miami

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.

Condition or disease
Mixed Connective Tissue Disease (MCTD) Systemic Lupus Erythematosus (SLE)

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 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.

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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

Primary Outcome Measures :
  1. Data characterizing immune cell responses and corresponding clinical data [ Time Frame: Up to 4 visits at intervals of at least 3 months. ]
  2. 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
Serum, cells, DNA, urine

Information from the National Library of Medicine

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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
Study Population
Systemic lupus erythematosus (SLE), rheumatoid arthritis (RA), mixed connective tissue disease (MCTD) or undifferentiated connective tissue disease (UCTD)

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).

Information from the National Library of Medicine

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

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Contact: Bethly Aubourg, MD 305-243-8567 baubourg@med.miami.edu
Contact: Eric L. Greidinger, MD 305-243-8913 egreidinger@med.miami.edu

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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   
Sponsors and Collaborators
University of Miami
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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Principal Investigator: Eric L. Greidinger, MD University of Miami
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric L. Greidinger, University of Miami:
Anti-RNP/Sm Autoantibody-Positive
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Mixed Connective Tissue Disease
Autoimmune Diseases
Immune System Diseases