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

NCT00582881 | Completed

• 3 other identifiers: 200307245R01AR043308-165R01AR043308-14
• Study Type: observational
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

Mixed Connective Tissue Disease (MCTD); Systemic Lupus Erythematosus (SLE)

Keywords

Anti-RNP/Sm Autoantibody-Positive; MCTD; SLE

Outcome Measures

Primary Outcomes (2)

• Data characterizing immune cell responses and corresponding clinical data

  Up to 4 visits at intervals of at least 3 months.

• Phenotype measurement to include disease activity, disease severity, and functional status

  up to 4 visits at intervals of at least 3 months

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• Patients with known rheumatic diseases including systemic lupus erythematosus, rheumatoid arthritis, connective tissue disease, undifferentiated connective tissue disease

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Miami: lead
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator

Study Sites (1)

University of Miami Miller School of Medicine

Miami, Florida, 33136, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Serum, cells, DNA, urine

MeSH Terms

Conditions

Mixed Connective Tissue Disease; Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Eric L. Greidinger, MD

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 28, 2007
• Study Start: October 1, 2007
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)