NCT01571206已完成1 期
An Open-Label, Single-Arm, Extension Study to Demonstrate Long-Term Efficacy and Safety of CT-P13 in Patients With Ankylosing Spondylitis Who Were Treated With Infliximab (Remicade or CT-P13) in Study CT-P13 1.1
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Celltrion
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) criteria and Long term safety evaluated by immunogenicity and clinical laboratory test
研究概览
简要总结
This open-label, single-arm, multicenter, multiple single-dose intravenous (IV) infusion, efficacy, and safety extension study of the Phase 1 Study CT-P13 1.1 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 1.1
- •Patient who has not had any major protocol violation in Study CT-P13 1.1
排除标准
- •Patient who has been withdrawn from Study CT-P13 1.1 for any reason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 option of the investigator
- •Patient who plans to participate in a study with an investigational drug during the period of this extension study
结局指标
主要结局
Long term efficacy evaluated by Assessment of Spondylo Arthritis International Society(ASAS) 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)
Loading locations...
相似试验
已完成
2 期
Open Label Trial on the Safety and Efficacy of Sym001 in the Treatment of Immune Thrombocytopenic Purpura (ITP)Immune Thrombocytopenic PurpuraNCT00718692Symphogen A/S61
招募中
不适用
A Study of the Safety and Preliminary Efficacy of LY-M001 Injection in the Treatment of Adult Patients with Gaucher Disease Type IGaucher Disease Type INCT06162338He Huang3
已完成
2 期
Study of Safety, Efficacy, Tolerability, Pharmacokinetics and Pharmacodynamics of LNP023 in in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)Paroxysmal Nocturnal Hemoglobinuria (PNH) With Signs of Active HemolysisNCT03439839Novartis Pharmaceuticals16
已完成
3 期
A Study of Intravenous Mircera in Participants With Chronic Renal Anemia Who Are on DialysisAnemiaNCT00660023Hoffmann-La Roche124
已完成
3 期
Safety, Efficacy, and Pharmacokinetic Study of Intravenous Ibuprofen in Pediatric PatientsFeverNCT01002573Cumberland Pharmaceuticals118