NCT00006134

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1993

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

August 3, 2000

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 4, 2000

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

August 3, 2000

Last Update Submit

June 23, 2005

Conditions

Systemic Lupus Erythematosus

Keywords

arthritis & connective tissue diseasesimmunologic disorders and infectious disordersrare diseasesystemic lupus erythematosus

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
* 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

University of Alabama Comprehensive Cancer Center

Birmingham, Alabama, 35294, United States

Location

University of Texas Medical Branch

Galveston, Texas, 77555-0209, United States

Location

University of Texas Health Science Center - Houston

Houston, Texas, 77225, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, SystemicArthritisConnective Tissue DiseasesImmune System DiseasesCommunicable DiseasesRare Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue DiseasesAutoimmune DiseasesJoint DiseasesMusculoskeletal DiseasesInfectionsDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Graciela S. Alarcon

    University of Alabama at Birmingham

    STUDY CHAIR

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

August 3, 2000

First Posted

August 4, 2000

Study Start

September 1, 1993

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(3)