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Systemic Lupus Erythematosus

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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.

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

Type of Study:

Observational

Study Design:

Primary Purpose: Screening

Principal Investigator

Graciela S. Alarcon

Investigator Role:

Study Chair

Investigator Affiliation:

University of Alabama at Birmingham

Authority:

United States: Federal Government

Study ID:

199/15328

NCT ID:

NCT00006134

Start Date:

September 1993

Completion Date:

Related Keywords:

  • Systemic Lupus Erythematosus
  • arthritis & connective tissue diseases
  • immunologic disorders and infectious disorders
  • rare disease
  • systemic lupus erythematosus
  • Lupus Erythematosus, Systemic

Name

Location

University of Alabama Comprehensive Cancer CenterBirmingham, Alabama  35294
University of Texas Medical BranchGalveston, Texas  77555-1329
University of Texas Health Science Center - HoustonHouston, Texas  77225