NCT01718951已完成4 期
Golimumab Versus Pamidronate for the Treatment of Axial Spondyloarthropathy: a 48-week Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response
研究概览
简要总结
To compare the efficacy of golimumab with pamidronate in the treatment of axial spondyloarthropathy
详细描述
To compare the efficacy of golimumab with pamidronate in the treatment of non-radiological axial spondyloarthropathy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
golimumab
Active Comparator
golimumab 50mg subcutaneous every 4 weeks
干预措施: golimumab (Drug)
pamidronate
Active Comparator
Pamidronate (60mg) intravenously every 4 weeks
干预措施: Pamidronate (Drug)
结局指标
主要结局
Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response response
时间窗: week 48
Proportion of patients who achieve the Assessment of SpondyloArthritis international Society criteria (ASAS)-20 response
次要结局
- Changes in MRI spinal inflammation scores(week 24 and 48)
研究者
Chi Chiu Mok
Consultant
Tuen Mun Hospital
研究点 (1)
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