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

May 11, 2015 updated by: Chi Chiu Mok, Tuen Mun Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Tuen Mun Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: golimumab
golimumab 50mg subcutaneous every 4 weeks
Drug: golimumab
golimumab
Other Names:
  • Simponi
ACTIVE_COMPARATOR: pamidronate
Pamidronate (60mg) intravenously every 4 weeks
Drug: Pamidronate
pamidronate
Other Names:
  • Aridia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
week 48

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in MRI spinal inflammation scores
Time Frame: week 24 and 48
Changes in MRI spinal inflammation scores
week 24 and 48

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tuen Mun Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

March 1, 2014

Study Completion (ACTUAL)

October 1, 2014

Study Registration Dates

First Submitted

October 29, 2012

First Submitted That Met QC Criteria

October 31, 2012

First Posted (ESTIMATE)

November 1, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2015

Last Update Submitted That Met QC Criteria

May 11, 2015

Last Verified

May 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CREC/769/09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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