Effect of Anti-TNF (Alpha) Treatment on Vascular Stiffness in Ankylosing Spondylitis (AS)

• 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
• 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 = 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



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)

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]

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]

Incremental cost-utility ratio of the treatment of Golimumab. [Time Frame: Month 12]

Effect of Golimumab treatment on the changes in arterial stiffness [Time Frame: Month 12]

Secondary ID(s)

AS_2010

Source(s) of Monetary Support

Please refer to primary and secondary sponsors