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

Phase 4

Completed

• Conditions: Spondyloarthropathy
• Interventions: Drug: Pamidronate; Drug: golimumab

• Registration Number: NCT01718951
• Lead Sponsor: Tuen Mun Hospital

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

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-31
• Study First Posted: 2012-11-01
• Primary Completion: 2014-03
• Study Completion: 2014-10
• Status Verified: 2015-05
• Last Update Submitted: 2015-05-11
• Last Update Posted: 2015-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pamidronate	Pamidronate	Pamidronate (60mg) intravenously every 4 weeks
golimumab	golimumab	golimumab 50mg subcutaneous every 4 weeks

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in MRI spinal inflammation scores	week 24 and 48	Changes in MRI spinal inflammation scores

Trial Locations

Locations (1)

Tuen Mun Hospital; 🇭🇰 Hong Kong, Hong Kong