Back to resultsGolimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
Primary Purpose
Spondyloarthropathy
Status
Completed
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
golimumab
Pamidronate
Sponsored by
About this trial
This is an interventional treatment trial for Spondyloarthropathy focused on measuring spondyloarthropathy, ankylosing spondylitis
Eligibility Criteria
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
Sites / Locations
- Tuen Mun Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
golimumab
pamidronate
Arm Description
golimumab 50mg subcutaneous every 4 weeks
Pamidronate (60mg) intravenously every 4 weeks
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Changes in MRI spinal inflammation scores
Changes in MRI spinal inflammation scores
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01718951
Brief Title
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
Official Title
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tuen Mun Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy
Detailed Description
To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spondyloarthropathy
Keywords
spondyloarthropathy, ankylosing spondylitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
golimumab
Arm Type
Active Comparator
Arm Description
golimumab 50mg subcutaneous every 4 weeks
Arm Title
pamidronate
Arm Type
Active Comparator
Arm Description
Pamidronate (60mg) intravenously every 4 weeks
Intervention Type
Drug
Intervention Name(s)
golimumab
Other Intervention Name(s)
Simponi
Intervention Description
golimumab
Intervention Type
Drug
Intervention Name(s)
Pamidronate
Other Intervention Name(s)
Aridia
Intervention Description
pamidronate
Primary Outcome Measure Information:
Title
Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response
Description
Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response
Time Frame
week 48
Secondary Outcome Measure Information:
Title
Changes in MRI spinal inflammation scores
Description
Changes in MRI spinal inflammation scores
Time Frame
week 24 and 48
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Tuen Mun Hospital
City
Hong Kong
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Trial
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