Skip to main content
OpenTrials
Completed

NCT Number: NCT01718951

Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial

To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spondyloarthropathy Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Musculoskeletal Diseases Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tuen Mun Hospital

Hong Kong

About this study

To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Subjects greater than 18 years of age
  • Fulfilling the latest classification criteria for axial spondyloarthropathy
  • Active spondylitis as defined by a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of more than 4 despite treatment with non-steroid anti-inflammatory drugs for more than 3 months

Exclusion criteria

  • Major surgery (including joint surgery) within 8 weeks prior to study entry
  • History of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry
  • Immunization with a live/attenuated vaccine within 4 weeks prior to study entry
  • Active current bacterial, viral, fungal, mycobacterial or other infections at study entry
  • Chronic hepatitis B or hepatitis C carriers
  • History of malignancies, including solid tumors and hemic malignancies
  • History of congestive heart failure
  • History of demyelinating disorders
  • History of peripheral neuropathy
  • Pregnant women or lactating mothers
  • Baseline liver parenchymal enzymes elevated to more than 2 times normal
  • Absolute lymphocyte count less than 500/mm3
  • Serum creatinine level of more than 200umol/L

Treatment and study plan

Golimumab

Drug

golimumab

Other names: Simponi

Pamidronate

Drug

pamidronate

Other names: Aridia

Primary outcomes

  1. Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response

    Time frame: week 48

    Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response

Secondary outcomes

  1. Changes in MRI spinal inflammation scores

    Time frame: week 24 and 48

    Changes in MRI spinal inflammation scores

Sponsors and collaborators

Lead sponsor

Tuen Mun Hospital

Other Gov

Registry information

Official study title

Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 1, 2012
Registry last updated
May 12, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.