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

Lupus Clinical Trial

— APL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00581763
• Other study ID #: H8994-19045
• Status: Completed
• Phase: N/A
• First received: December 19, 2007
• Last updated: June 11, 2012
• Start date: May 2001
• Est. completion date: June 2011

Study information

• Verified date: June 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 21 Years

Eligibility

Inclusion Criteria:

Age: Less than 21 years at baseline exam

• Diagnosis: patients must meet criteria for one of five diagnostic categories based on classification according to three parameters; aPL positivity, APS criteria, and SLE criteria.

The five diagnostic categories are:

• SLE with no aPL

• SLE with aPL, but without manifestations of APS

• SLE-like APS

• SLE with APS

• Primary APS.

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lupus

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate changes and improve ability to determine the long-term outcome of affected individuals		Ten years	No