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
  Purpose

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.


Condition Intervention
Systemic Lupus Erythematosus
Other: Peripheral lab draws

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus

Resource links provided by NLM:


Further study details as provided by The Center for Rheumatic Disease, Allergy, & Immunology:

Estimated Enrollment: 75
Study Start Date: April 2005
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Female Lupus patients
Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling.
Other: Peripheral lab draws
100ml blood for analysis, taken no more than 4 times in one year.

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519454

Contacts
Contact: Nabih I Abdou, MD, PhD. 816-531-0930 niabdou@centerforrheumatic.com
Contact: Cindy Greenwell, RN 816-531-0930 cindy@centerforrheumatic.com

Locations
United States, Missouri
The Center for Rheumatic Disease, Allergy and Immunology Recruiting
Kansas City, Missouri, United States, 64111
Contact: Nabih I Abdou, MD, PhD    816-531-0930    niabdou@centerforrheumatic.com   
Contact: Cindy A Greenwell, RN    816-531-0930    cindy@centerforrheumatic.com   
Principal Investigator: Nabih I Abdou, MD, PhD         
Sponsors and Collaborators
The Center for Rheumatic Disease, Allergy, & Immunology
AstraZeneca
Investigators
Principal Investigator: Nabih I Abdou, MD, PhD The Center for Rheumatic Disease, Allergy and Immunology
  More Information

No publications provided

Responsible Party: Nabih I Abdou, Center for Rheumatic Disease Allergy & Immunology
ClinicalTrials.gov Identifier: NCT00519454     History of Changes
Other Study ID Numbers: 05-024
Study First Received: August 20, 2007
Last Updated: September 3, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by The Center for Rheumatic Disease, Allergy, & Immunology:
Systemic Lupus Erythematosus
Estrogen receptors
T cells
Hormones
Female adult SLE

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 23, 2014