A Phase 4 interventional study of Simponi and 0.9ml sodium chloride in Ankylosing Spondylitis(AS), sponsored by Chinese University of Hong Kong. Completed at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2014-09-11.
Sponsored by Chinese University of Hong Kong · Phase 4, Interventional, and Treatment
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.
623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.
This study's enrollment of 50 is below the median of 92 across 349 interventional studies indexed under Spondylitis.
Browse Spondylitis studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
In this 52-week, randomized, placebo-controlled study, patients will be randomized to receive either golimumab 50 mg monthly or matching placebo for 12 months using a 1:1 randomization procedure. The doctors and patients and the nurse who administer the study medication (Golimumab) will be blinded. There will be one unblinded nurse to prepare the study medication.
Drug: Simponi
In this 52-week, randomized, placebo-controlled study, patients will be randomized to receive either Golimumab 50 mg monthly or matching placebo for 12 months using a 1:1 randomization procedure. The doctors and patients and the nurse who administer the study medication (Golimumab) will be blinded. There will be one unblinded nurse to prepare the study medication.
Other: 0.9ml sodium chloride
Golimumab 50mg monthly
Also known as: Golimumab
0.9ml sodium chloride
Effect of Golimumab treatment on the progression of subclinical atherosclerosis
Effect of Golimumab treatment on the progression of subclinical atherosclerosis at 12 months compared with baseline as evaluated by Intima-Media Thickness (IMT).
Time frame: Month 12
Effect of Golimumab treatment on the changes in arterial stiffness
Effect of Golimumab on changes in arterial stiffness at 12 months compared with baseline as evaluated by Pulse Wave Velocity and Augmentation Index.
Time frame: Month 12
Changes on the number and function of Endothelial Progenitor Cells in Ankylosing Spondylitis before and after 1 year of Golimumab compared with baseline.
The number and function of EPCs before and after golimumab will be assessed using Wilcoxin-sign rank test
Time frame: Month 12
To correlate the changes in Intima-Media Thickening, Pulse Wave Velocity, Augmentation Index and Endothelial Progenitor Cells with the changes in markers of disease activity.
Correlation between the change in disease activity markers (BASDAI, ESR, CRP, and MRI global activity score) and the change in IMT, PWV and AIx and EPC number will be assessed using Spearman's test
Time frame: Month 12
Incremental cost-utility ratio of the treatment of Golimumab.
Utility will be assessed using the EuroQol 5D (EQ5D) and the Short-Form 36 (SF-36), at baseline and every visit.Utility is used to calculate quality-adjusted life years (QALYs). The incremental cost-utility ratio expressed as "(annual costs of golimumab treatment - annual costs of placebo treatment) / additional QALY gain by golimumab treatment" is calculated.
Time frame: Month 12
This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong