Systemic Lupus ErythematosusPhase 2NCT00417430
Efficacy of Faslodex in Treatment of SLE Clinical, Serologic, and Molecular Studies
A Phase 2 study testing ICI 182,780 (Faslodex) in people with Systemic Lupus Erythematosus, run by The Center for Rheumatic Disease, Allergy, & Immunology at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 16 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- ICI 182,780 (Faslodex)
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Dec 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Premenopausal women with SLE
- Without life-threatening manifestations
- With regular menstrual cyles not on hormones of any kind
Who cannot join
- For any of the following:
- Increase of SLEDAI greater than 12
- If life-threatening manifestations occur
- If menstruation ceases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- ICI 182,780 (Faslodex)
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICI 182,780 (Faslodex)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved SLEDAI
Improved Disease Lab parameters
Measurement of the estrogen receptors from start to finish
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startSep 2004
- Primary completionDec 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Enrolment
- 20 participants
Sponsor and investigators
- Lead sponsor
- The Center for Rheumatic Disease, Allergy, & Immunology
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Nabih Abdou, MD, PhD, Principal investigator, Center for Rheumatic Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417430
- Sponsor's protocol ID
- 03-082
- Status last verified
- Sep 2009
- First submitted
- 28 Dec 2006
- Last updated
- 22 Sep 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Efficacy of ICI 182,780 (Faslodex) in the Treatment of Systemic Lupus Erythematosus: Clinical, Serologic, Molecular
- ClinicalTrials.gov ID
- NCT00417430
- Acronym / sponsor ID
- 03-082
- Conditions
- Systemic Lupus Erythematosus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants
- Lead sponsor
- The Center for Rheumatic Disease, Allergy, & ImmunologyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Sep 2004
- Primary completion
- Dec 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 1 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Premenopausal women with SLE
- Without life-threatening manifestations
- With regular menstrual cyles not on hormones of any kind
Key exclusion criteria (4 listed)
- Increase of SLEDAI greater than 12
- If life-threatening manifestations occur
- If menstruation ceases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICI 182,780 (Faslodex) | Drug | – |
Primary outcome
Improved SLEDAI
Improved Disease Lab parameters
Measurement of the estrogen receptors from start to finish
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabih Abdou, MD, PhD principal investigator
Center for Rheumatic Disease
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ICI 182,780 (Faslodex) in people with Systemic Lupus Erythematosus, run by The Center for Rheumatic Disease, Allergy, & Immunology at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Sep 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved SLEDAI. The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2009.