Estrogen and Gender Biased Autoimmunity

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by The Center for Rheumatic Disease, Allergy, & Immunology.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
AstraZeneca
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology
ClinicalTrials.gov Identifier:
NCT00519454
First received: August 20, 2007
Last updated: September 3, 2010
Last verified: September 2010

August 20, 2007
September 3, 2010
April 2005
December 2013   (final data collection date for primary outcome measure)
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Not Provided
Complete list of historical versions of study NCT00519454 on ClinicalTrials.gov Archive Site
Not Provided
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Estrogen and Gender Biased Autoimmunity
Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Female subjects with SLE and still cycling, not on hormones, compared to normal controls, female subjects still cycling, also not on hormones and not diagnosed with SLE.

Systemic Lupus Erythematosus
Other: Peripheral lab draws
100ml blood for analysis, taken no more than 4 times in one year.
Female Lupus patients
Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling.
Intervention: Other: Peripheral lab draws
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
75
December 2013
December 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 50 Years
Yes
Contact: Nabih I Abdou, MD, PhD. 816-531-0930 niabdou@centerforrheumatic.com
Contact: Cindy Greenwell, RN 816-531-0930 cindy@centerforrheumatic.com
United States
 
NCT00519454
05-024
No
Nabih I Abdou, Center for Rheumatic Disease Allergy & Immunology
The Center for Rheumatic Disease, Allergy, & Immunology
AstraZeneca
Principal Investigator: Nabih I Abdou, MD, PhD The Center for Rheumatic Disease, Allergy and Immunology
The Center for Rheumatic Disease, Allergy, & Immunology
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP