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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 19 February 2015
Main ID:  NCT01212653
Date of registration: 30/09/2010
Prospective Registration: Yes
Primary sponsor: Chinese University of Hong Kong
Public title: Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS) AS
Scientific title: Effect of Anti-TNF(Alpha)Treatment on Circulating Endothelial Progenitor Cells (EPCs) and Vascular Stiffness in AS
Date of first enrolment: October 2010
Target sample size: 50
Recruitment status: Completed
URL:  http://clinicaltrials.gov/show/NCT01212653
Study type:  Interventional
Study design:  Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment  
Phase:  Phase 4
Countries of recruitment
China
Contacts
Name:     Lai Shan Tam, MD
Address: 
Telephone:
Email:
Affiliation:  Chinese University of Hong Kong
Key inclusion & exclusion criteria

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 = 270┬Ámol/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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Ankylosing Spondylitis(AS)
Intervention(s)
Drug: Simponi
Other: 0.9ml sodium chloride
Primary Outcome(s)
Effect of Golimumab treatment on the progression of subclinical atherosclerosis [Time Frame: Month 12]
Secondary Outcome(s)
Changes on the number and function of Endothelial Progenitor Cells in Ankylosing Spondylitis before and after 1 year of Golimumab compared with baseline. [Time Frame: Month 12]
Effect of Golimumab treatment on the changes in arterial stiffness [Time Frame: Month 12]
Incremental cost-utility ratio of the treatment of Golimumab. [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. [Time Frame: Month 12]
Secondary ID(s)
AS_2010
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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