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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Arthritis Autoimmune Diseases Communicable Diseases Connective Tissue Diseases Disease Attributes Immune System Diseases Infections Joint Diseases Lupus Erythematosus, Systemic Musculoskeletal Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Rare Diseases Skin and Connective Tissue Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama Comprehensive Cancer Center, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Sponsors and collaborators

Lead sponsor

National Center for Research Resources (NCRR)

Nih

Collaborators

University of Alabama at Birmingham

Registry information

Important dates

Study start: 1993
First posted: Aug 4, 2000
Registry last updated: Jun 24, 2005

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed