NCT00519454

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 22, 2007

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

September 8, 2010

Status Verified

September 1, 2010

Enrollment Period

8.7 years

First QC Date

August 20, 2007

Last Update Submit

September 3, 2010

Conditions

Keywords

Systemic Lupus ErythematosusEstrogen receptorsT cellsHormonesFemale adult SLE

Study Arms (1)

Female Lupus patients

Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling.

Other: Peripheral lab draws

Interventions

100ml blood for analysis, taken no more than 4 times in one year.

Female Lupus patients

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Center for Rheumatic Disease, Allergy and Immunology

Kansas City, Missouri, 64111, United States

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Nabih I Abdou, MD, PhD

    The Center for Rheumatic Disease, Allergy and Immunology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Nabih I Abdou, MD, PhD.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 20, 2007

First Posted

August 22, 2007

Study Start

April 1, 2005

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

September 8, 2010

Record last verified: 2010-09

Locations