Autoimmunity in Sisters of Lupus Patients

Systemic Lupus Erythematosus Clinical Trial

— SisSLE  

Official title:

Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076101
• Other study ID #: 09-263
• Secondary ID: R01AI068759
• Status: Completed
• Phase: N/A
• First received: February 24, 2010
• Last updated: February 2, 2017
• Start date: February 2009
• Est. completion date: December 31, 2016

Study information

• Verified date: February 2017
• Source: Northwell Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 817
• Est. completion date: December 31, 2016
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 10 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

Locations

Country	Name	City	State
United States	The Feinstein Institute for Medical Research	Manhasset	New York

Sponsors (2)

Lead Sponsor	Collaborator
Northwell Health	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		5 years
Secondary	To understand the preclinical biological and immunological events that precede the development of systemic lupus		5 years