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Characteristics and Disease Progression of Mixed Connective Tissue Disease and Systemic Lupus Erythematosus
This study is currently recruiting participants.
Verified by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), March 2009
First Received: December 19, 2007   Last Updated: March 31, 2009   History of Changes
Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
ClinicalTrials.gov Identifier: NCT00582881
  Purpose

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
Mixed Connective Tissue Disease
Systemic Lupus Erythematosus

Study Type: Observational
Study Design: Cohort, Cross-Sectional
Official Title: Immune Response to Small Nuclear Ribonucleoprotein Autoantigens

Resource links provided by NLM:


Further study details as provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):

Primary Outcome Measures:
  • Data characterizing CD4 T cells and corresponding clinical data [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]
  • Phenotype measurement to include disease activity, disease severity, and functional status [ Time Frame: Every 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Blood cell DNA


Estimated Enrollment: 400
Study Start Date: October 2007
Estimated Study Completion Date: September 2012
Estimated Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with MCTD and SLE

Criteria

Inclusion Criteria:

  • Presence of anti-RNP or anti-Sm antibodies

Exclusion Criteria:

  • Lacking at least two criteria for MCTD or two criteria for SLE after the 1-year follow-up visit
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00582881

Contacts
Contact: Judith Pignac-Kobinger, MS 305-243-8567 jpignac@med.miami.edu
Contact: Robert W. Hoffman, DO 305-243-6866 rhoffman@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33101
Contact: Judith Pignac-Kobinger, MS     305-243-8567     Jpignac@med.miami.edu    
Sponsors and Collaborators
Investigators
Principal Investigator: Robert W. Hoffman, DO University of Miami Miller School of Medicine
  More Information

No publications provided

Responsible Party: University of Miami Miller School of Medicine ( Robert W. Hoffman )
Study ID Numbers: R01 AR043308, 2R01 AR 043308-12A1
Study First Received: December 19, 2007
Last Updated: March 31, 2009
ClinicalTrials.gov Identifier: NCT00582881     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS):
Anti-RNP/Sm Autoantibody-Positive
MCTD
SLE

Additional relevant MeSH terms:
Autoimmune Diseases
Immune System Diseases
Lupus Erythematosus, Systemic
Mixed Connective Tissue Disease
Connective Tissue Diseases

ClinicalTrials.gov processed this record on November 27, 2009