NCT01220518已完成1 期
Randomized, Double-blind, Parallel-group, Phase 1 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- PK equivalence to remicade
研究概览
简要总结
This study is the trial to demonstrate how our product is similar to remicade by comparing the results of blood samples in active Ankylosing Spondylitis patients.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosed with active ankylosing spondylitis
- •BASDAI score ≥ 4 and visual analogue scale(VAS) score of spinal pain ≥ 4
排除标准
- •have total ankylosing of spine
- •have allergies to infliximab
- •serious infection
研究组 & 干预措施
CT-P13
Active Comparator
infliximab
干预措施: Infliximab (Drug)
Remicade
Active Comparator
infliximab
干预措施: Infliximab (Drug)
结局指标
主要结局
PK equivalence to remicade
时间窗: PK sampling at week 22
次要结局
- Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 20% criteria(at week 14, 30 and 54)
- Proportion of patients achieving clinical response according to the Assessment of SpondyloArthritis International Society (ASAS) 40 criteria(at week 14, 30 and 54)
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) at Weeks 14, 30 and 54 compared with Baseline(at week 14, 30 and 54)
- Bath Ankylosing Spondylitis Functional Index (BASFI) at Weeks 14, 30 and 54 compared with Baseline(at week 14, 30 and 54)
- Bath Ankylosing Spondylitis Metrology Index (BASMI) at Weeks 14, 30 and 54 compared with Baseline(at weeks 14, 30 and 54)
- Chest expansion at Weeks 14, 30 and 54 compared with Baseline(at weeks 14, 30 and 54)
- Quality of life questionnaire (SF-36)(at week 14, 30 and 54)
研究者
研究点 (1)
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