Status:
COMPLETED
Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS)
Lead Sponsor:
Chinese University of Hong Kong
Conditions:
Ankylosing Spondylitis(AS)
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
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 thi...
Detailed Description
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 Spondyliti...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2013
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01212653
Start Date
October 1 2010
End Date
May 1 2013
Last Update
September 11 2014
Active Locations (1)
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1
Prince of Wales Hospital
Hong Kong, China