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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01718951

Enrollment

Registered

2012-11-01

Start date

2012-08-31

Completion date

2014-10-31

Last updated

2015-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Spondyloarthropathy

Keywords

spondyloarthropathy, ankylosing spondylitis

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

Interventions

DRUGgolimumab

golimumab

DRUGPamidronate

pamidronate

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response	week 48	Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response

Secondary

Measure	Time frame	Description
Changes in MRI spinal inflammation scores	week 24 and 48	Changes in MRI spinal inflammation scores

Countries

Hong Kong

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026