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

Spondyloarthropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01718951
• Other study ID #: CREC/769/09
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2012
• Last updated: May 11, 2015
• Start date: August 2012
• Est. completion date: October 2014

Study information

• Verified date: May 2015
• Source: Tuen Mun Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Spondylarthropathies
• Spondyloarthropathy

Intervention

Drug:
• golimumab
golimumab
• Pamidronate
pamidronate

Locations

Country	Name	City	State
Hong Kong	Tuen Mun Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
Tuen Mun Hospital

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	week 48	No
Secondary	Changes in MRI spinal inflammation scores	Changes in MRI spinal inflammation scores	week 24 and 48	No