Clinical trial NCT01076101: Autoimmunity in Sisters of Lupus Patients
Official title: Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: SLE
sister
autoimmune disease
Lead sponsor: Northwell Health
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2010-02-25
Enrollment: 817
Sex: FEMALE
Minimum age (years): 10
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: FAMILY_BASED
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Sister Diagnosed with SLE:

Inclusion Criteria:

1. Proband must be a female and have documented SLE that meets ACR criteria. SLE must be diagnosed by and including age 40.
2. 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.

Exclusion Criteria:

If inclusion criteria above are met for the proband, there are no exclusions.

Sister who does not have SLE:

Inclusion Criteria:

1. Female with a full or half sister who has been documented SLE that meets ACR criteria.
2. Sister must be currently between ages ≥ 10 and ≤ 45 at the time of enrollment and not have a diagnosis of SLE.
3. Sister must be able to complete questionnaires and should be willing to donate a blood sample at baseline and follow-up.
4. 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.

Exclusion Criteria:

If Sister meets inclusion criteria, there will be no exclusions.

Primary outcomes:
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
timeFrame: 5 years
Secondary outcomes:
measure: To understand the preclinical biological and immunological events that precede the development of systemic lupus
timeFrame: 5 years
Other outcomes:
Locations:
city: Manhasset
country: United States
facility: The Feinstein Institute for Medical Research
state: New York
Study officials:
affiliation: NorthShore -LIJ The Feinstein Institute for Medical Research
name: Peter K Gregersen, MD
role: PRINCIPAL_INVESTIGATOR
References: