Systemic Lupus ErythematosusSisSLENCT01076101
Autoimmunity in Sisters of Lupus Patients
An observational study of Systemic Lupus Erythematosus, run by Northwell Health at 1 site in United States.
Trial summary
This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample. Read more about this study
- Who is it for?
- Ages 10 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 817 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to 31 Dec 2016
- How long will I take part?
- 7 Years
- 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 10 to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Sisters: One sister must be diagnosed with Systemic Lupus Erythematous ( SLE ) by and including age 40 who has a sister(s) or half sister(s) not affected with SLE currently between the ages of 10 and 45 are being recruited nation wide through community and physician referrals.
Who may be able to join
- Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40.
- Proband must have at least one biological sister ≥ 10 years of age and ≤ 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify.
- Female with a full or half sister who has been documented SLE that meets ACR criteria.
- Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE.
- Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up.
- Sister should communicate to the recruiter that she is willing to be followed for a period of at least two years by phone and/or internet.
Who cannot join
- If inclusion criteria above are met for the proband, there are no exclusions.
- Sister who does not have SLE:
- If Sister meets inclusion criteria, there will be no exclusions.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Feinstein Institute for Medical Research
Manhasset, New York, 11030
About this study
Official title: Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)
This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
Read the detailed description
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that causes inflammation and is accompanied by the development of autoantibodies. The inflammation caused by SLE may affect the skin, joints, lungs, blood, kidneys and nervous system. The cause of SLE is unknown, but research has indicated that it is caused by a combination of genetic and environmental factors.
Autoimmune diseases often run in families. Close relatives of people with these diseases are at greater risk of developing the same or another autoimmune disease. The study is designed to determine several things: If sisters of people with SLE make the same antibodies that are present in people with SLE, whether or not environmental factors affect the chances of developing these antibodies and if so what these environmental factors may be, if the presence of these antibodies in healthy people leads to increased risk for the development of SLE.
This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
Participation is voluntary and participants can stop participating at any time.
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, sister, autoimmune disease
- Medical subject headings
- Lupus Erythematosus, Systemic, Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Sisters who have a diagnosis of SLE | Sisters who have a diagnosis of SLE | |
| Unaffected Sisters | Sisters of SLE patients who do not have a diagnosis of SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify biomarkers that can predict the future development of clinical disease in subjects at risk, or alternatively, indicate that progression to overt clinical disease is unlikely
Measured: 5 years
Secondary outcomes (1)
To understand the preclinical biological and immunological events that precede the development of systemic lupus
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2010 (estimated)
- Study startFeb 2009
- Primary completion31 Dec 2016
- Study completion31 Dec 2016
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.
- More trials run by Northwell HealthThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 817 participants (actual)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Gregersen, Northwell Health
- Investigators
- Peter K Gregersen, MD, Principal investigator, NorthShore -LIJ The Feinstein Institute for Medical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01076101
- Sponsor's protocol ID
- 09-263
- Other IDs
- R01AI068759
- Acronym
- SisSLE
- Status last verified
- Feb 2017
- First submitted
- 24 Feb 2010
- Last updated
- 6 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)
- ClinicalTrials.gov ID
- NCT01076101
- Acronym / sponsor ID
- SisSLE / 09-263
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- SLE, sister, autoimmune disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 817 participants (actual)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID)
- Study start
- Feb 2009
- Primary completion
- 31 Dec 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 25 Feb 2010 (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 enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
Detailed description
Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease that causes inflammation and is accompanied by the development of autoantibodies. The inflammation caused by SLE may affect the skin, joints, lungs, blood, kidneys and nervous system. The cause of SLE is unknown, but research has indicated that it is caused by a combination of genetic and environmental factors.
Autoimmune diseases often run in families. Close relatives of people with these diseases are at greater risk of developing the same or another autoimmune disease. The study is designed to determine several things: If sisters of people with SLE make the same antibodies that are present in people with SLE, whether or not environmental factors affect the chances of developing these antibodies and if so what these environmental factors may be, if the presence of these antibodies in healthy people leads to increased risk for the development of SLE.
This study enrolled over 400 unaffected sisters of young women diagnosed with SLE. These unaffected sisters are being followed with an annual health questionnaire (CSQ) and blood sample.
Participation is voluntary and participants can stop participating at any time.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sisters who have a diagnosis of SLE | – | –Sisters who have a diagnosis of SLE |
| Unaffected Sisters | – | –Sisters of SLE patients who do not have a diagnosis of SLE |
Who may qualify
- Ages
- 10 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Sisters: One sister must be diagnosed with Systemic Lupus Erythematous ( SLE ) by and including age 40 who has a sister(s) or half sister(s) not affected with SLE currently between the ages of 10 and 45 are being recruited nation wide through community and physician referrals.
Key inclusion criteria (6 listed)
- Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40.
- Proband must have at least one biological sister ≥ 10 years of age and ≤ 45 who is available and willing to donate a blood sample and enroll in a longitudinal study. Both full and half siblings qualify.
- Female with a full or half sister who has been documented SLE that meets ACR criteria.
- Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE.
- Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up.
Key exclusion criteria (3 listed)
- If inclusion criteria above are met for the proband, there are no exclusions.
- If Sister meets inclusion criteria, there will be no exclusions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To identify biomarkers that can predict the future development of clinical disease in subjects at risk, or alternatively, indicate that progression to overt clinical disease is unlikely
Time frame: 5 years
1 secondary outcome
To understand the preclinical biological and immunological events that precede the development of systemic lupus
Time frame: 5 years
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 6 Feb 2017.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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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.
Peter K Gregersen, MD principal investigator
NorthShore -LIJ The Feinstein Institute for Medical Research
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 Northwell Health 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 6 inclusion and 3 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 6 Feb 2017. 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?
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?
To identify biomarkers that can predict the future development of clinical disease in subjects at risk, or alternatively, indicate that progression to overt clinical disease is unlikely (time frame: 5 years). 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 6 Feb 2017.