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

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tuen Mun Hospital
• Treatments: Antibodies, Monoclonal; Golimumab; Pamidronate

Criteria

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