Systemic Lupus ErythematosusNCT00519454
Estrogen and Gender Biased Autoimmunity
An observational study of Systemic Lupus Erythematosus, run by The Center for Rheumatic Disease, Allergy, & Immunology at 1 site in United States.
Trial summary
This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Peripheral lab draws
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2005to Dec 2013
- Phase
- Observational
- 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 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Female subjects with SLE and still cycling, not on hormones, compared to normal controls, female subjects still cycling, also not on hormones and not diagnosed with SLE.
Who may be able to join
- female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.
Who cannot join
- Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
The Center for Rheumatic Disease, Allergy and Immunology
Kansas City, Missouri, 64111
Nabih I Abdou, MD, PhD, 816-531-0930, niabdou@centerforrheumatic.com
Cindy A Greenwell, RN, 816-531-0930, cindy@centerforrheumatic.com
About this study
Official title: Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus
This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.
Read the detailed description
This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Peripheral lab draws
- Keywords
- Systemic Lupus Erythematosus, Estrogen receptors, T cells, Hormones, Female adult SLE
- 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.
Peripheral lab drawsOther
100ml blood for analysis, taken no more than 4 times in one year.
| Study group | Role | What they receive |
|---|---|---|
| Female Lupus patients | Females who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling. Receives: Other: Peripheral lab draws |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2007 (estimated)
- Study startApr 2005
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Center for Rheumatic Disease, Allergy, & Immunology
- Sponsor type
- University, hospital or other
- Collaborators
- AstraZeneca
- Investigators
- Nabih I Abdou, MD, PhD, Principal investigator, The Center for Rheumatic Disease, Allergy and Immunology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519454
- Sponsor's protocol ID
- 05-024
- Status last verified
- Sep 2010
- First submitted
- 20 Aug 2007
- Last updated
- 8 Sep 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estrogen and Gender Biased Autoimmunity in Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT00519454
- Acronym / sponsor ID
- 05-024
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Estrogen receptors, T cells, Hormones, Female adult SLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- The Center for Rheumatic Disease, Allergy, & ImmunologyUniversity, hospital or other
- Collaborators
- AstraZeneca
- Study start
- Apr 2005
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 22 Aug 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.
This study involves research to investigate how estrogen affects women of childbearing age and its correlation to Systemic Lupus Erythematosus. The findings from this study might help determine how body cells, called T Cells, react to estrogen. The study will seek to determine if cells from women with Lupus, react differently from cells in persons without Lupus. We will attempt to identify genetic factors that determine the effects of estrogen on Lupus cells.
Detailed description
This is a 3-year study. The total number of subjects enrolled will depend on the results obtained. The subjects will be at least 18 years of age and pre-menopausal. Exclusion to include pregnant women, and all subjects are told not to get pregnant while on study. Also, they cannot take hormones by mouth or patch while on study. The study can include healthy subjects as well. Blood will be drawn (120 ml) four times a year, randomly.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Female Lupus patients | – | Other: Peripheral lab drawsFemales who are still childbearing age, not on hormones, with Systemic Lupus Erythematosus, still cycling. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Female subjects with SLE and still cycling, not on hormones, compared to normal controls, female subjects still cycling, also not on hormones and not diagnosed with SLE.
Key inclusion criteria (1 listed)
- female subjects with Lupus, and female subjects without Lupus. age at least 18, not pregnant and not planning to get pregnant.
Key exclusion criteria (1 listed)
- Pregnant or planning to get pregnant. On hormone replacement, or birth control of any kind.
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 |
|---|---|---|
| Peripheral lab draws100ml blood for analysis, taken no more than 4 times in one year. | Other | Female Lupus patients |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2010.
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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 I Abdou, MD, PhD principal investigator
The Center for Rheumatic Disease, Allergy and Immunology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 8 Sep 2010. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nabih I Abdou, MD, PhD. (816-531-0930, niabdou@centerforrheumatic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
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 8 Sep 2010.