NCT02809300

Brief Summary

The main objective is to evaluate the prevalence of anti-phospholipid antibodies (APLA) in patients with ankylosing spondylitis (AS). The secondary objectives are: (1) To determine whether the presence of these antibodies is symptomatic (thrombosis or not); (2) Identify a possible relationship between the presence of APLA and a particular form of SA (axial or peripheral); (3) To determine whether the presence of APLA is more frequent in patients receiving anti-tumor necrosis factor (TNF) alpha therapy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 20, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
Last Updated

June 23, 2016

Status Verified

June 1, 2016

Enrollment Period

1.3 years

First QC Date

June 20, 2016

Last Update Submit

June 22, 2016

Conditions

Ankylosing Spondylarthritis

Outcome Measures

Primary Outcomes (1)

  • presence or absence of APLA

    12 weeks

Study Arms (1)

ankylosing spondylarthritis

EXPERIMENTAL
Biological: blood collection

Interventions

blood collectionBIOLOGICAL
ankylosing spondylarthritis

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than 18 years
  • with SA according to ASAS criteria
  • followed in the Internal Medicine Department of the REIMS University Hospital
  • who have given their consent
  • affiliated to social security insurance

You may not qualify if:

  • minor patients
  • patients with autoimmune disease (except the inflammatory bowel disease)
  • cancer
  • coagulation disorders
  • anticoagulant treatment (anticoagulation out for events history thrombus embolism)
  • pregnant women
  • patients protected by law

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu Reims

France, Reims, 51092, France

RECRUITING

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Axial SpondyloarthritisSpondylarthropathiesSpondylarthritisSpondylitisSpinal DiseasesBone DiseasesMusculoskeletal DiseasesAnkylosisJoint DiseasesArthritis

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Central Study Contacts

Pauline ORQUEVAUD

CONTACT

326832465porquevaux@chu-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2016

First Posted

June 22, 2016

Study Start

November 1, 2015

Primary Completion

March 1, 2017

Last Updated

June 23, 2016

Record last verified: 2016-06

Locations

FR(1)