Clinical Trial: Ankylosing Spondylitis and Antiphospholipid Antibodies

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients

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.

Detailed Summary:

Methods:

Experimental design: longitudinal study prospective in a single center.

The Ankylosing Spondylitis Assesment Study (ASAS) criteria are: (1) age <45 years, back pain ≥ 3 months, sacroiliitis on imaging and ≥ 1 associated minor criterion, or (2) HLA B27 positive and ≥ 2 minor criteria.

Minor criteria are: inflammatory back pain, arthritis, enthesitis, uveitis, Dactylitis, psoriasis, Crohn's disease, good clinical response to NSAIDs, family history of Human Leukocyte Antigen HLA B27 and inflammatory syndrome.

Plan Investigation:

Patients in the study will be seen first in consultation to gather the necessary information: history taking (including venous and arterial embolic events and obstetric history), the usual treatment, ASAS criteria of therapeutic AS, current and previous, comprehensive physical examination.

APLA will be measured at baseline and at least 3 months if initially positive.

OUTCOME:

The primary endpoint is the presence or absence of APLA: anti-cardiolipin antibodies (CLA) immunoglobulin M (IgM) or immunoglobulin G (IgG), circulating anticoagulant lupus (CCA), anti-beta2 glycoprotéine1 antibodies (β2GP1A) IgM or IgG.

The secondary endpoints are:

• The presence of thrombosis (past or present) or obstetrical accident (anterior)
• Relationship between the presence of APLA and a particular form of AS (axial or periphera
  Sponsor: CHU de Reims
  

  Current Primary Outcome: presence or absence of APLA [ Time Frame: 12 weeks ]
  
  

  Original Primary Outcome: presence or absence of APA [ Time Frame: 12 weeks ]
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: CHU de Reims
  

  Dates:
  Date Received: June 20, 2016
  Date Started: November 2015
  Date Completion:
  Last Updated: June 22, 2016
  Last Verified: June 2016