NCT01571219已完成3 期
An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 When Co-Administered With Methotrexate in Patient With Rheumatoid Arthritis Who Were Treated With Infliximab(Remicade or CP-P13) in Study CT-P13 3.1
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 302
- 试验地点
- 1
- 主要终点
- Long term efficacy evaluated by American College of Rheumatology(ACR) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test
研究概览
简要总结
CT-P13 (Infliximab) is a monoclonal antibody currently being developed by CELLTRION, Inc. This open-label, single-arm, multicenter, multiple single dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 3 Study CT-P13 3.1 is designed to assess the long-term efficacy and safety of multiple doses of CT-P13.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Patient who has completed the scheduled visits, including the End-of-Study Visit, in Study CT-P13 3.1
- •Patient who has not had any major protocol violation in Study CT-P13 3.1
- •Patient is permitted to enter the extension study if, in the option of their general practitioner or the investigator, the patient will continue to gain benefit from treatment in the extension study. Local guidelines for patient treatment will be followed
排除标准
- •Patient who has been withdrawn from Study CT-P13 3.1 for any reason
- •Patient who, at the time of providing informed consent, has any ongoing medical issues such as serious adverse events (SAEs) or intolerance issues that mean continuation in this extension study could be detrimental to their health, in the opinion of the investigator
- •Patient who plans to participate in a study with an investigational drug during the period of this extension study
研究组 & 干预措施
CT-P13
Experimental
干预措施: Infliximab (Biological)
结局指标
主要结局
Long term efficacy evaluated by American College of Rheumatology(ACR) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test
时间窗: Up to week 40
次要结局
未报告次要终点
研究者
研究点 (1)
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