Recruiting

Observational Study

Sponsor:

Medical University of South Carolina

Code:

NCT00756769

Conditions

Systemic Lupus Erythematosus

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Study Details

Brief summary:

Systemic lupus erythematosus (SLE) is an autoimmune disease characterized by the production of autoantibodies, multiple organ involvement, and diverse clinical symptoms and immunologic manifestations. African Americans are at a disproportionately higher risk of developing SLE, develop SLE at an earlier age, and have increased morbidity and mortality compared with European Americans. Our central study hypothesis is that there are specific genetic factors that interact with environmental exposures leading to the development of SLE. The African American Gullah population from the Sea Islands of South Carolina and Georgia are unique in their genetic homogeneity with minimal non-African genetic admixture, making them an ideal cohort to address questions of environmental and genetic influence on the development and progression of SLE.

Conditions

Systemic Lupus Erythematosus

Study ID

NCT00756769

Start date

Apr, 2003

Status verified date

Jul, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • Age 2 years and above;
  • Self-identified as African-American "Gullah" from the Sea Island region of South Carolina;
  • Have had at least 4 of the 11 diagnostic criteria for SLE as designated by the American College of Rheumatology (ACR), be a relative of a known SLE patient, or be an unrelated healthy Gullah control;
  • Ability to speak and understand English;
  • Ability and willingness to give informed consent

Exclusion Criteria:

  • Race defined by participant as other than Black or African-American;
  • Being a prisoner, mentally ill patient, or institutionalized individual;
  • Unwilling or unable to give informed consent

Study Design

Enrollment

750 participants

Anticipated

Interventions and Outcome Measures

Arms

1

Patients with SLE

2

Related unaffected controls

3

Unrelated unaffected controls

Central Contacts and Locations

Central contacts

Diane L. Kamen, MD, MSCR

843-792-4825kamend@musc.edu

Locations

Medical University of South Carolina

Recruiting

Charleston, South Carolina, United States, 29425

More Information

Sponsor

Medical University of South Carolina

Last update posted

Jul 28, 2026

Last verified

Jul, 2026

Keywords

  • African Americans

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Medical University of South Carolina on 2026-07-28.