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Estrogen and Gender Biased Autoimmunity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2010 by The Center for Rheumatic Disease, Allergy, & Immunology.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00519454
First Posted: August 22, 2007
Last Update Posted: September 8, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
AstraZeneca
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology
August 20, 2007
August 22, 2007
September 8, 2010
April 2005
December 2013   (Final data collection date for primary outcome measure)
Not Provided
Not Provided
Complete list of historical versions of study NCT00519454 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
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
Not Provided
Not Provided
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.
 
Unknown status
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.
Sexes Eligible for Study: Female
18 Years to 50 Years   (Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00519454
05-024
No
Not Provided
Not Provided
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