Estrogen and Gender Biased Autoimmunity

Systemic Lupus Erythematosus Clinical Trial

Official title:

Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00519454
• Other study ID #: 05-024
• Status: Recruiting
• Phase: N/A
• First received: August 20, 2007
• Last updated: September 3, 2010
• Start date: April 2005
• Est. completion date: December 2013

Study information

• Verified date: September 2010
• Source: The Center for Rheumatic Disease, Allergy, & Immunology
• Contact: Nabih I Abdou, MD, PhD.
• Phone: 816-531-0930
• Email: niabdou[@]centerforrheumatic.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.

Description:

This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.

Exclusion Criteria:

• Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Autoimmune Diseases
• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Other:
• Peripheral lab draws
100ml blood for analysis, taken no more than 4 times in one year.

Locations

Country	Name	City	State
United States	The Center for Rheumatic Disease, Allergy and Immunology	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Rheumatic Disease, Allergy, & Immunology	AstraZeneca

Country where clinical trial is conducted

United States,