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

• Status: Completed
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: The Center for Rheumatic Disease, Allergy, & Immunology
• Collaborator: AstraZeneca
• Treatments: Estradiol; Fulvestrant

Criteria

Inclusion Criteria:

• Premenopausal women with SLE

• Without life-threatening manifestations

• With regular menstrual cyles not on hormones of any kind

Exclusion Criteria:

For any of the following:

• Increase of SLEDAI greater than 12

• If life-threatening manifestations occur

• If menstruation ceases