Ankylosing Spondylarthritis Clinical Trial
Official title:
Prevalence of Antiphospholipid Antibodies in Ankylosing Spondylitis: A Study of 80 Patients
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.
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
peripheral)
- Relationship between the presence of APLA and anti-TNF alpha therapy
Calendar:
The expected study duration is 16 months.
Statistical Analysis Plan A descriptive analysis will be performed. The variables are
described by their number and percentage; quantitative variables are described by their mean
and standard deviation. A calculation of the prevalence of APLA will be made. Univariate
analysis will be performed for the secondary objectives by the Chi 2 test or Fisher exact
test according to the application conditions.
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05427942 -
Yuflyma® (Adalimumab), Patient Experience After Switching
|