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

NCT01212653 | Completed Phase 4 DMC

• 1 other identifier: AS_2010
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

1. 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. 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. 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. 4.To perform cost-effectiveness and cost-utility analyses of the Golimumab in Ankylosing Spondylitis(AS) patients, using clinic-base data.

Conditions

Ankylosing Spondylitis(AS)

Keywords

Ankylosing Spondylitis; Golimumab; Simponi; Anti-TNF alpha; EPCs; Vascular stiffness

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Effect of Golimumab treatment on the changes in arterial stiffness

  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.

  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.

  Month 12

• Incremental cost-utility ratio of the treatment of Golimumab.

  Month 12

Study Arms (2)

Golimumab

ACTIVE COMPARATOR

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

Pacebo-controlled

PLACEBO COMPARATOR

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

Interventions

Simponi DRUG

Golimumab 50mg monthly

Also known as: Golimumab

Golimumab

0.9ml sodium chloride OTHER

0.9ml sodium chloride

Pacebo-controlled

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Hong Kong, China

Location

Related Publications (1)

• Tam LS, Shang Q, Kun EW, Lee KL, Yip ML, Li M, Li TK, Zhu TY, Pui MO, Li EK, Yu CM. The effects of golimumab on subclinical atherosclerosis and arterial stiffness in ankylosing spondylitis-a randomized, placebo-controlled pilot trial. Rheumatology (Oxford). 2014 Jun;53(6):1065-74. doi: 10.1093/rheumatology/ket469.

  PMID: 24501241 DERIVED

MeSH Terms

Conditions

Spondylitis, Ankylosing

Interventions

golimumab; Sodium Chloride

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lai Shan Tam, MD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 30, 2010
• First Posted: October 1, 2010
• Study Start: October 1, 2010
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: September 11, 2014

Record last verified: 2014-09

Locations

CN (1)