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

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ClinicalTrials.gov Identifier: NCT00417430
Recruitment Status : Completed
First Posted : January 1, 2007
Last Update Posted : September 22, 2009
Information provided by:
The Center for Rheumatic Disease, Allergy, & Immunology

December 28, 2006
January 1, 2007
September 22, 2009
September 2004
December 2006   (Final data collection date for primary outcome measure)
  • Improved SLEDAI
  • Improved Disease Lab parameters
  • Measurement of the estrogen receptors from start to finish
Same as current
Complete list of historical versions of study NCT00417430 on ClinicalTrials.gov Archive Site
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Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies
Phase II Study of Efficacy of ICI 182,780 (Faslodex) in the Treatment of Systemic Lupus Erythematosus: Clinical, Serologic, Molecular
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.
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.
Phase 2
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Systemic Lupus Erythematosus
Drug: ICI 182,780 (Faslodex)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
December 2006
December 2006   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Female
16 Years to 50 Years   (Child, Adult)
Contact information is only displayed when the study is recruiting subjects
United States
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Nabih I Abdou, MD, PhD, Center for Rheumatic Disease Allergy & Immunology
The Center for Rheumatic Disease, Allergy, & Immunology
Principal Investigator: Nabih Abdou, MD, PhD Center for Rheumatic Disease
The Center for Rheumatic Disease, Allergy, & Immunology
September 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP