Autoimmunity in Sisters of Lupus Patients (SisSLE)

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.

Study Overview

• Status: Completed
• Conditions: Systemic Lupus Erythematosus

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 Type: Observational
• Enrollment (Actual): 817

Contacts and Locations

Study Locations

• United States
  • New York
    • Manhasset, New York, United States, 11030
      • The Feinstein Institute for Medical Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 45 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Sisters who have a diagnosis of SLE
Unaffected Sisters; Sisters of SLE patients who do not have a diagnosis of SLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
To understand the preclinical biological and immunological events that precede the development of systemic lupus	5 years

Collaborators and Investigators

• Sponsor: Northwell Health
• Collaborators: National Institute of Allergy and Infectious Diseases (NIAID)
• Investigators: Principal Investigator: Peter K Gregersen, MD, NorthShore -LIJ The Feinstein Institute for Medical Research

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (Actual): December 31, 2016
• Study Completion (Actual): December 31, 2016

Study Registration Dates

• First Submitted: February 24, 2010
• First Submitted That Met QC Criteria: February 24, 2010
• First Posted (Estimate): February 25, 2010

Study Record Updates

• Last Update Posted (Estimate): February 6, 2017
• Last Update Submitted That Met QC Criteria: February 2, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: SLE; autoimmune disease; sister
• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: 09-263; R01AI068759 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No