Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies — APL  

Lupus Clinical Trial

Official title: Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies

Status Completed

Clinical Trial Summary

This is a study about why some people have certain types of proteins in their blood, called anti-phospholipid antibodies. The presence of these antibodies and associated complications (e.g. blood clots) are known to change over time. The purpose of this study is to evaluate these changes and improve our ability to determine the long-term outcome of affected individuals.

Clinical Trial Description

Aim:

1. Determine the incidence, and time frame, for aquiring aPL in a cohort of aPL-negative pediatric SLE subjects.

2. Determine the incidence, and time frame, for developing a first APS-associated complication among SLE subjects with detectable aPL.

3. Determine the incidence, and time frame, for developing a second APS-associated event among subjects with a history of an APS-associated event.

4. Determine the incidence, and time frame, for developing SLE among subjects with a history of an APS-associated event in the absence of SLE.

5. Identify laboratory and clinical predictors for the events described in aims 1-4.Research Design and Methods:

This is a prospective cohort study to determine the risk of developing aPL or APS-related symptoms in a young group of SLE and APS subjects. Patients will be followed over a ten year period and will undergo annual serologic and clinical evaluations to identify disease progression. ;

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus

• NCT number: NCT00581763
• Study type: Observational
• Source: University of California, San Francisco
• Status: Completed
• Phase: N/A
• Start date: May 2001
• Completion date: June 2011