Skip to main content
OpenTrials
Completed

NCT Number: NCT01076101

Autoimmunity in Sisters of Lupus Patients

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

10 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

The Feinstein Institute for Medical Research

Manhasset, New York, 11030, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Sister Diagnosed with SLE:

Inclusion criteria

  • 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.

Exclusion criteria

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

Sister who does not have SLE:

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. To understand the preclinical biological and immunological events that precede the development of systemic lupus

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

Northwell Health

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Mapping Autoimmune Phenotypes in Multiplex Families (MADGC 2)

Acronym: SisSLE

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Feb 25, 2010
Registry last updated
Feb 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.