Systemic Lupus Erythematosus in Gullah Health

Systemic Lupus Erythematosus Clinical Trial

— SLEIGH  

Official title:

Systemic Lupus Erythematosus in Gullah Health

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00756769
• Other study ID #: MUSC HR10852
• Secondary ID: P60AR049459
• Status: Recruiting
• Start date: April 2003
• Est. completion date: June 2027

Study information

• Verified date: November 2023
• Source: Medical University of South Carolina
• Contact: Diane L. Kamen, MD, MSCR
• Phone: 843-792-4825
• Email: kamend[@]musc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 750
• Est. completion date: June 2027
• Est. primary completion date: June 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Medical University of South Carolina	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kamen DL, Barron M, Parker TM, Shaftman SR, Bruner GR, Aberle T, James JA, Scofield RH, Harley JB, Gilkeson GS. Autoantibody prevalence and lupus characteristics in a unique African American population. Arthritis Rheum. 2008 May;58(5):1237-47. doi: 10.100 — View Citation