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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: ICI 182,780 (Faslodex)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ICI 182,780 (Faslodex)|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved SLEDAI |  |  | 
| Improved Disease Lab parameters |  |  | 
| Measurement of the estrogen receptors from start to finish |  |  |