NCT00076713

Brief Summary

Antiphospholipid Syndrome (APS) is an autoimmune disorder in which the body recognizes certain normal components of blood and/or cell membranes as foreign substances and produces antibodies against them. Patients with these antibodies may experience miscarriages and blood clotting disorders, including heart attacks and strokes. APS may occur in people with systemic lupus erythematosus and other autoimmune diseases, or in otherwise healthy individuals. The Antiphospholipid Syndrome Collaborative Registry (APSCORE) is a national registry and tissue repository for patients with APS. This registry will collect clinical information and blood samples from people with APS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
860

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2000

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2000

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

February 2, 2004

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 3, 2004

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

7 years

First QC Date

February 2, 2004

Last Update Submit

February 11, 2013

Conditions

Keywords

Antiphospholipid

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Specialty and subspecialty clinics

You may qualify if:

  • Antiphospholipid antibodies with or without associated clinical manifestations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Morehouse School of Medicine

Atlanta, Georgia, 30310, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Hospital for Special Surgery, Weill-Cornell University Medical Center

New York, New York, 10021, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Texas Health Science Center

San Antonio, Texas, 78229, United States

Location

University of Utah Health Science Center

Salt Lake City, Utah, 84132, United States

Location

Related Publications (1)

  • Roubey RA. New approaches to prevention of thrombosis in the antiphospholipid syndrome: hopes, trials, and tribulations. Arthritis Rheum. 2003 Nov;48(11):3004-8. doi: 10.1002/art.11332. No abstract available.

    PMID: 14613259BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Serum, plasma, genomic DNA

MeSH Terms

Conditions

Antiphospholipid Syndrome

Condition Hierarchy (Ancestors)

Autoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 2, 2004

First Posted

February 3, 2004

Study Start

April 1, 2000

Primary Completion

April 1, 2007

Study Completion

April 1, 2007

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations