CClinicalTrials.gg
CompletedNCT01718951Updated May 12, 2015

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

A Phase 4 interventional study of golimumab and Pamidronate in Spondyloarthropathy, sponsored by Tuen Mun Hospital. Completed at 1 site in Hong Kong. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by Tuen Mun Hospital · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Spondyloarthropathy

Keywords

  • spondyloarthropathy
  • ankylosing spondylitis
03

In context

Spondylitis

623 studies on the registry are indexed under Spondylitis; 83 are open to participants now.

This study's enrollment of 30 is below the median of 92 across 349 interventional studies indexed under Spondylitis.

Browse Spondylitis studies →

Lead sponsor

Tuen Mun Hospital is the lead sponsor of 24 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Subjects greater than 18 years of age
  2. Fulfilling the latest classification criteria for axial spondyloarthropathy
  3. 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

Exclusion Criteria:

  1. Major surgery (including joint surgery) within 8 weeks prior to study entry
  2. History of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry
  3. Immunization with a live/attenuated vaccine within 4 weeks prior to study entry
  4. Active current bacterial, viral, fungal, mycobacterial or other infections at study entry
  5. Chronic hepatitis B or hepatitis C carriers
  6. History of malignancies, including solid tumors and hemic malignancies
  7. History of congestive heart failure
  8. History of demyelinating disorders
  9. History of peripheral neuropathy
  10. Pregnant women or lactating mothers
  11. Baseline liver parenchymal enzymes elevated to more than 2 times normal
  12. Absolute lymphocyte count less than 500/mm3
  13. Serum creatinine level of more than 200umol/L
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    golimumab

    golimumab 50mg subcutaneous every 4 weeks

    Drug: golimumab

  • Active comparator
    pamidronate

    Pamidronate (60mg) intravenously every 4 weeks

    Drug: Pamidronate

Interventions

  • Druggolimumab

    golimumab

    Also known as: Simponi

  • DrugPamidronate

    pamidronate

    Also known as: Aridia

06

What researchers measure

Primary outcomes

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

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

    Time frame: week 48

Secondary outcomes

  1. Changes in MRI spinal inflammation scores

    Changes in MRI spinal inflammation scores

    Time frame: week 24 and 48

07

Study locations

1 site
  • Tuen Mun Hospital
    Hong Kong, Hong Kong
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01718951
Lead sponsor
Tuen Mun Hospital
Responsible party
Chi Chiu Mok (Consultant, Tuen Mun Hospital) — Principal investigator
First posted
Nov 1, 2012
Start date
Aug 2012
Primary completion
Mar 2014
Completion
Oct 2014
Last update
May 12, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2015. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion