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Study of the Predictors of the Course and Early Outcome of Patients With Systemic Lupus Erythematosus: Nature Versus Nurture

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00006134
Enrollment
300
Registered
2000-08-04
Start date
1993-09-30
Completion date
Unknown
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Systemic Lupus Erythematosus

Keywords

arthritis & connective tissue diseases, immunologic disorders and infectious disorders, rare disease, systemic lupus erythematosus

Brief summary

OBJECTIVES: I. Continue yearly ascertainment visits of all patients of the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) study cohort. II. Recruit into the LUMINA cohort newly diagnosed patients with systemic lupus erythematosus (SLE). III. Determine the impact of additional major histocompatibility complex (MHC) and non-MHC genetic factors not previously examined, specifically tumor necrosis factor, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2, on the course and outcome of SLE. IV. Refine the assessment of those clinical and behavioral-cultural factors found to be important predictors of disease activity, damage, and functioning, thus far in these patients. V. Determine the relationships among disease activity, disease damage, and physical and mental functioning in these patients as the SLE progresses and the factors that predict them.

Detailed description

PROTOCOL OUTLINE: This is a parallel, follow up study of a natural history study. Patients are stratified according to ethnicity (Caucasian vs African-American vs Hispanic). Patients are examined at baseline and then every 6 months thereafter in order to determine the relative impact of genetic, sociodemographic, and behavioral-cultural factors on disease outcome. Patients are assessed for the following outcome variables: disease activity by the Systemic Lupus Activity Measure (SLAM), disease damage by the Systemic Lupus International Collaborative Clinics Damage Index (SDI), and physical and mental functioning by the Medical Outcomes Study 36 Item Short-Form Health Survey (SF-36). Patients are also assessed for independent variables belonging to the following domains: socioeconomic-demographic, clinical, immunogenetic, and behavioral-cultural. Patients undergo genetic analysis utilizing polymerase chain reaction and electrophoresis to further study the immunogenetic domain and genetic markers that may be related to disease. Specifically, patients' blood is analyzed for tumor necrosis factor alpha, tumor necrosis factor beta, mannose binding protein, interleukin-1 receptor antagonist, and bcl-2.

Interventions

None listed

Sponsors

University of Alabama at Birmingham
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Eligibility

Sex/Gender
ALL
Age
0 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* All systemic lupus erythematosus (SLE) patients currently constituting the established Lupus in Minority Populations: Nature vs Nurture (LUMINA) cohort OR New recruits meeting at least 4 of the 1997 American College of Rheumatology criteria for the classification of SLE * Disease onset within the past 5 years * African-American, Hispanic, or Caucasian Self stated, plus the same for all 4 grandparents * No concurrent participation in any intervention studies * Not pregnant * Not mentally retarded * No prisoners * No other concurrent disability that would preclude study

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026