NCT00417430

Brief Summary

SLE(Systemic Lupus Erythematosus) is an autoimmune disese that primarily occurs in women(9:1 compared to men). The disease is activated by genetic and environmental factors, yet the female gender is the strongest risk factor. The sex hormone estrogen has been proven in the past to be an enhancer of the immune response. Estrogen serves as a ligand for two specific receptor proteins. Lab studies that we have already done have shown estrogen significantly increases these two ligands in the T cells from SLE females, but not in T cells from normal women. These estrogen-dependent increases are blocked by the estrogen receptor antagonist ICI 182,780. The objective of this research is to investigate if ICI 182,780 alters disease progression and/or activity in females with SLE and may provide a new treatment for women with SLE. This is based on previous work we have done.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Sep 2004

Geographic Reach
1 country

1 active site

Status
completed

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

September 1, 2004

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

December 28, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 1, 2007

Completed
Last Updated

September 22, 2009

Status Verified

September 1, 2009

Enrollment Period

2.2 years

First QC Date

December 28, 2006

Last Update Submit

September 18, 2009

Conditions

Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (3)

  • Improved SLEDAI

  • Improved Disease Lab parameters

  • Measurement of the estrogen receptors from start to finish

Interventions

ICI 182,780 (Faslodex)DRUG

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Premenopausal women with SLE
  • Without life-threatening manifestations
  • With regular menstrual cyles not on hormones of any kind

You may not qualify if:

  • For any of the following:
  • Increase of SLEDAI greater than 12
  • If life-threatening manifestations occur
  • If menstruation ceases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

4330 Wornall suite 40

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Nabih Abdou, MD, PhD

    Center for Rheumatic Disease

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 28, 2006

First Posted

January 1, 2007

Study Start

September 1, 2004

Primary Completion

December 1, 2006

Study Completion

December 1, 2006

Last Updated

September 22, 2009

Record last verified: 2009-09

Locations

US(1)