Characteristics and Disease Progression of Mixed Connective Tissue Disease and Lupus
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)
🗓️ Study Start (Actual) October 2007
🗓️ Primary Completion (Estimated) September 2027
✅ Study Completion (Estimated) September 2029
👥 Enrollment (Estimated) 400
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Miami, Florida, United States

📋 Eligibility Criteria

Description

    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).
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 19 December 2007
  • First Submitted that Met QC Criteria 19 December 2007
  • First Posted 28 December 2007

Study Record Updates

  • Last Update Submitted that Met QC Criteria 29 February 2024
  • Last Update Posted 1 March 2024
  • Last Verified February 2024