Estrogen and Gender Biased Autoimmunity

September 3, 2010 updated by: The Center for Rheumatic Disease, Allergy, & Immunology

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Recruiting
        • The Center for Rheumatic Disease, Allergy and Immunology
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nabih I Abdou, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Collaborators

AstraZeneca

Investigators

  • Principal Investigator: Nabih I Abdou, MD, PhD, The Center for Rheumatic Disease, Allergy and Immunology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2005

Primary Completion (Anticipated)

December 1, 2013

Study Completion (Anticipated)

December 1, 2013

Study Registration Dates

First Submitted

August 20, 2007

First Submitted That Met QC Criteria

August 21, 2007

First Posted (Estimate)

August 22, 2007

Study Record Updates

Last Update Posted (Estimate)

September 8, 2010

Last Update Submitted That Met QC Criteria

September 3, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 05-024

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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