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

Study Overview
=================
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

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

Conditions
-----------------
Spondyloarthropathy

Intervention / Treatment
-----------------
* Drug: golimumab
* Drug: Pamidronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects greater than 18 years of age Fulfilling the latest classification criteria for axial spondyloarthropathy 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: Major surgery (including joint surgery) within 8 weeks prior to study entry History of treatment with anti-tumor necrosis factor agents or any investigational therapies within 12 months of study entry Immunization with a live/attenuated vaccine within 4 weeks prior to study entry Active current bacterial, viral, fungal, mycobacterial or other infections at study entry Chronic hepatitis B or hepatitis C carriers History of malignancies, including solid tumors and hemic malignancies History of congestive heart failure History of demyelinating disorders History of peripheral neuropathy Pregnant women or lactating mothers Baseline liver parenchymal enzymes elevated to more than 2 times normal Absolute lymphocyte count less than 500/mm3 Serum creatinine level of more than 200umol/L

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: golimumab<br>golimumab 50mg subcutaneous every 4 weeks | Drug: golimumab<br>* golimumab<br>* Other names: Simponi;|
| Active Comparator: pamidronate<br>Pamidronate (60mg) intravenously every 4 weeks | Drug: Pamidronate<br>* pamidronate<br>* Other names: Aridia;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in MRI spinal inflammation scores | Changes in MRI spinal inflammation scores | week 24 and 48 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
spondyloarthropathy, ankylosing spondylitis