Ankylosing Spondylitis(AS) Clinical Trial
Official title:
Effect of Anti-TNF(Alpha)Treatment on Circulating Endothelial Progenitor Cells (EPCs) and Vascular Stiffness in AS
1. To determine the effect of Golimumab treatment on the number and function of
Endothelial Progenitor Cells (EPCs) in Ankylosing Spondylitis(AS) patients as a
possible mechanism for the effect of this treatment on endothelial function.
2. To ascertain the effect of Golimumab treatment on , carotid intima-media thickness,
vascular stiffness in Ankylosing Spondylitis(AS) patients as measured by pulse wave
velocity (PWV) and Augmentation index (AIx).
3. To assess the clinical efficacy of Golimumab in Chinese Ankylosing Spondylitis(AS)
patients according to ASAS response criteria at month 3, 6 and 12.
4. To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing
Spondylitis(AS) patients, using clinic-base data.
This study will provide important data on the pathogenesis of vascular damage and possible
mechanism by which potent anti-inflammatory treatment may reduce cardiovascular risk in
Ankylosing Spondylitis(AS) patients.
Fifty patients with Ankylosing Spondylitis(AS) will be randomized to receive either
Golimumab or Placebo for 12 months. Patients randomized to Placebo with worsening disease
activity (failure to achieve Assessment of SpondyloArthritis international Society (ASAS20))
at week 24 will be permitted to escape to open-label Golimumab. Clinical assessment,
intima-media thickness, vascular stiffness and endothelial progenitor cells will be
performed at baseline, 6 and 12 months.
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Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment