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OpenTrials
Completed

NCT Number: NCT00417430

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

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.

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

4330 Wornall suite 40

Kansas City, Missouri, 64111, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ICI 182,780 (Faslodex)

Drug

Primary outcomes

  1. Improved SLEDAI

  2. Improved Disease Lab parameters

  3. Measurement of the estrogen receptors from start to finish

Sponsors and collaborators

Lead sponsor

The Center for Rheumatic Disease, Allergy, & Immunology

Other

Collaborators

  • AstraZeneca

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Jan 1, 2007
Registry last updated
Sep 22, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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