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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Miami
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eric L. Greidinger, University of Miami
ClinicalTrials.gov Identifier:
NCT00582881
First received: December 19, 2007
Last updated: February 10, 2014
Last verified: February 2014
  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 (MCTD)
Systemic Lupus Erythematosus (SLE)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Immune Response to Small Nuclear Ribonucleoprotein Autoantigens

Resource links provided by NLM:


Further study details as provided by University of Miami:

Primary Outcome Measures:
  • Data characterizing immune cell responses and corresponding clinical data [ Time Frame: Up to 4 visits at intervals of at least 3 months. ] [ Designated as safety issue: No ]
  • Phenotype measurement to include disease activity, disease severity, and functional status [ Time Frame: up to 4 visits at intervals of at least 3 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum, cells, DNA, urine


Estimated Enrollment: 400
Study Start Date: October 2007
Estimated Study Completion Date: April 2015
Estimated Primary Completion Date: July 2014 (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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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)

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: Eric L. Greidinger, MD 305-243-8913 egreidinger@med.miami.edu

Locations
United States, Florida
University of Miami Miller School of Medicine Recruiting
Miami, Florida, United States, 33136
Contact: Judith Pignac-Kobinger, MS    305-243-8567    Jpignac@med.miami.edu   
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Eric L. Greidinger, MD University of Miami
  More Information

No publications provided

Responsible Party: Eric L. Greidinger, Chief, Division of Rheumatology; Associate Professor of Medicine, University of Miami
ClinicalTrials.gov Identifier: NCT00582881     History of Changes
Other Study ID Numbers: R01 AR043308, 5R01AR043308-16, 5R01AR043308-14
Study First Received: December 19, 2007
Last Updated: February 10, 2014
Health Authority: United States: Federal Government

Keywords provided by University of Miami:
Anti-RNP/Sm Autoantibody-Positive
MCTD
SLE

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

ClinicalTrials.gov processed this record on August 28, 2014