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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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

Brief 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.

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Drug: ICI 182,780 (Faslodex) Phase 2

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Phase II Study of Efficacy of ICI 182,780 (Faslodex) in the Treatment of Systemic Lupus Erythematosus: Clinical, Serologic, Molecular
Study Start Date : September 2004
Actual Primary Completion Date : December 2006
Actual Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus
Drug Information available for: Fulvestrant

Primary Outcome Measures :
  1. Improved SLEDAI
  2. Improved Disease Lab parameters
  3. Measurement of the estrogen receptors from start to finish

Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00417430

United States, Missouri
4330 Wornall suite 40
Kansas City, Missouri, United States, 64111
Sponsors and Collaborators
The Center for Rheumatic Disease, Allergy, & Immunology
Principal Investigator: Nabih Abdou, MD, PhD Center for Rheumatic Disease

Responsible Party: Nabih I Abdou, MD, PhD, Center for Rheumatic Disease Allergy & Immunology Identifier: NCT00417430     History of Changes
Other Study ID Numbers: 03-082
First Posted: January 1, 2007    Key Record Dates
Last Update Posted: September 22, 2009
Last Verified: September 2009

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs