Trial Information

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.