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

Systemic Lupus Erythematosus Clinical Trial

Official title:

Phase II Study of Efficacy of ICI 182,780 (Faslodex) in the Treatment of Systemic Lupus Erythematosus: Clinical, Serologic, Molecular

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00417430
• Other study ID #: 03-082
• Status: Completed
• Phase: Phase 2
• First received: December 28, 2006
• Last updated: September 18, 2009
• Start date: September 2004
• Est. completion date: December 2006

Study information

• Verified date: September 2009
• Source: The Center for Rheumatic Disease, Allergy, & Immunology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

This is a double-blind study, involving (goal) 20 women with SLE. All will be premenopausal with regular menstrual cycles. Patients will meet at least four of the criteria of the American Colleges of Rheumatology for classification of SLE. Disease activity will be determined by SLE disease activity index called SLEDAI scores. Patients can take meds to control their disease, but none will be able to take birth control pills/patches, or hormone replacement at the time of the study. The pharmacy will be in control of the blind and 10 will get ICI 182,780 (Faslodex) and 10 will get placebo. Lab will be drawn before each injection and a bone density will be done on injection 1 and 12, the injections will be monthly, depending on the female's cycle. A visit will be done at month 15 to evaluate SLEDAI, and draw lab as well. Each vs will have a SLEDAI done with the clinical evaluation. The injection is 250mg/5cc, which is divided into 2 injections of 2.5cc each, given IM, on day 4-10 of each cycle.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Intervention

Drug:
• ICI 182,780 (Faslodex)

Locations

Country	Name	City	State
United States	4330 Wornall suite 40	Kansas City	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
The Center for Rheumatic Disease, Allergy, & Immunology	AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improved SLEDAI
Primary	Improved Disease Lab parameters
Primary	Measurement of the estrogen receptors from start to finish