NCT01217086已完成3 期
Randomized, Double-blind, Parallel-group, Phase 3 Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 617
- 试验地点
- 1
- 主要终点
- PK equivalence to remicade
研究概览
简要总结
This is the trial to see how our product is similar to remicade by comparing the results of blood samples when co-administered with methotrexate between 12.5 to 25 mg/week, oral or parenteral dose and folic acid in rheumatoid arthritis patients who are not receiving adequate response to methotrexate alone up to week 30.
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 rheumatoid arthritis
- •at least 3 months of treatment with methotrexate
排除标准
- •have allergies to infliximab
- •serious infection
研究组 & 干预措施
CT-P13
Active Comparator
干预措施: Infliximab (Drug)
Remicade
Active Comparator
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 30
次要结局
- efficacy endpoint(Up to week 54.)
研究者
研究点 (1)
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