Understanding Mixed Connective Tissue Disease and Systemic Lupus Erythematosus
Immune Response to Small Nuclear Ribonucleoprotein Autoantigens
This study is trying to learn more about how mixed connective tissue disease and lupus affect the immune system and body, so they can help create better treatments for people with these conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 400 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Miami Academic / other |
| Drugs / interventions | methotrexate, cyclophosphamide |
| Locations | 1 site (Miami, Florida) |
| Trial ID | NCT00582881 on ClinicalTrials.gov |
What this trial studies
This study aims to characterize the immune system abnormalities, genetic factors, and disease progression in individuals diagnosed with mixed connective tissue disease (MCTD) and systemic lupus erythematosus (SLE). Participants will attend up to four study visits over the course of the study, where they will complete questionnaires, undergo physical exams, and provide blood and urine samples. The research focuses on understanding how these autoimmune diseases affect various body systems and the potential genetic components involved. By gathering this information, the study seeks to contribute to the development of new and effective treatments for these conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with systemic lupus erythematosus or mixed connective tissue disease.
Not a fit: Patients with unstable medical conditions, significant cardiopulmonary disease, or those on high doses of corticosteroids or cytotoxic drugs may not benefit from this study.
Why it matters
Potential benefit: If successful, this research could lead to improved understanding and treatment options for patients with MCTD and SLE.
How similar studies have performed: Previous studies have explored aspects of SLE and MCTD, but this specific characterization approach may provide novel insights into these diseases.
Eligibility criteria
Show full inclusion / exclusion 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).
Where this trial is running
Miami, Florida
- University of Miami Miller School of Medicine — Miami, Florida, United States (Recruiting)
Study contacts
- Principal investigator: Eric L. Greidinger, MD — University of Miami
- Study coordinator: Bethly Aubourg, MD
- Email: baubourg@med.miami.edu
- Phone: 305-243-8567
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.