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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00581763
First received: December 19, 2007
Last updated: June 11, 2012
Last verified: June 2012
  Purpose

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.


Condition
Lupus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Long-Term Outcome of Children and Adolescents With Anti-Phospholipid Antibodies

Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Evaluate changes and improve ability to determine the long-term outcome of affected individuals [ Time Frame: Ten years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Enrollment: 110
Study Start Date: May 2001
Study Completion Date: June 2011
Groups/Cohorts
Observation
Those with a condition

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Young group of SLE and APS subjects

Criteria

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:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00581763

Locations
United States, California
University of California, San Francisco
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Emily von Scheven University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00581763     History of Changes
Other Study ID Numbers: H8994-19045
Study First Received: December 19, 2007
Last Updated: June 11, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Antibodies
Antibodies, Antiphospholipid
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 27, 2014