Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies

Completed · Phase 2

Conditions studied: Systemic Lupus Erythematosus

In brief

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.

Key facts

Study ID

NCT00417430

Run by

The Center for Rheumatic Disease, Allergy, & Immunology

People needed

20

Starts

2004-09-01

Expected to finish

2006-12-01

Last updated by the study team

2009-09-22

Who can join

Age: 16 and older, up to 50. Sex: female. Healthy volunteers: accepted.

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

Where it is running

• 4330 Wornall suite 40 — Kansas City, Missouri, United States

Full record on ClinicalTrials.gov

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