Ankylosing Spondylitis(AS) Clinical Trial
— ASOfficial 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.
| Status | Completed |
| Enrollment | 50 |
| Est. completion date | May 2013 |
| Est. primary completion date | May 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 75 Years |
| Eligibility |
Inclusion Criteria: - Men or women, 18 years of age or older - Fulfilled the modified New York diagnostic criteria for Ankylosing spondylitis (AS)for more than 3 months - Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) = 4 (0-10 point scale), Pain visual analog scale(VAS) = 4 (0-10cm scale) - Inadequate response to at least two Nonsteroidal Antiinflammatory Drugs (NASID) on highest recommended doses for 3 months or unable to receive full 3-month course because of intolerance,toxicity or contraindications - Normal Chest X-ray within 3 months before baseline - Purified Protein Derivative(PPD) negative, or Latent Tuberculosis (TB) patients were required therapy for Tuberculosis (TB) before or simultaneously with first dose of study agent Exclusion Criteria: - Complete ankylosis of the spine - Concurrent with other inflammatory rheumatic disease - Serious infection (treatment with IV-infective) within 2 months before randomization - Active Tuberculosis (TB) or recent contact with a person with active Tuberculosis (TB) - An opportunistic infection within 6 months of screening - Known history of Hepatitis, Human Immunodeficiency Virus (HIV), Malignancy, a transplanted organ, multiple sclerosis, congestive heart failure - Currently on systemic immunosuppressives, DMARDS (other than Methotrexate, Sulfasalazine , or Hydroxychloroquine), or Leflunomide within 4 week before first study agent - Any previous use of Alefacept, Efalizumab, Rituximab, Golimumab or Natalizumab - Use of cytotoxic drugs, received intra-articular, intramuscular, or intravenous corticosteroids in the past 4 weeks before screening - Clinically significant renal disease (serum creatinine level = 270µmol/L), alanine aminotransferase (ALT) = 2 x upper limit of normal (ULN) - Hemoglobin level < 8.5gm/dl, a white blood cell count < 3.5x 109/liter, a platelet count < 100x 109/liter - Female of childbearing potential, unwilling to use adequate contraception during the study - Pregnant or breastfeeding women |
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| China | Prince of Wales Hospital | Hong Kong |
| Lead Sponsor | Collaborator |
|---|---|
| Chinese University of Hong Kong |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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). | Month 12 | Yes |
| Secondary | 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. | Month 12 | Yes |
| Secondary | 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 | Month 12 | Yes |
| Secondary | 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 | Month 12 | Yes |
| Secondary | 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. | Month 12 | Yes |