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

Tuen Mun Hospital

Status and phase: Completed; Phase 4

Conditions: Spondyloarthropathy

Treatments: Drug: Pamidronate; Drug: golimumab

Study type: Interventional

Funder types: Other

Identifiers

NCT01718951

CREC/769/09

Details and patient eligibility

About

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

Full description

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

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

golimumab

Active Comparator group

Description:

golimumab 50mg subcutaneous every 4 weeks

Treatment:

Drug: golimumab

pamidronate

Active Comparator group

Description:

Pamidronate (60mg) intravenously every 4 weeks

Treatment:

Drug: Pamidronate