NCT02846961已完成不适用
Occurrence of Anti-drug Antibody and Change of Drug Level for 1 Year After CT-P13 Therapy and Their Impact on Clinical Outcomes in Moderate to Severe Inflammatory Bowel Disease (OACIS Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Development of anti-drug antibody to CT-P13
研究概览
简要总结
The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Crohn's disease or ulcerative colitis
排除标准
- •Tuberculosis infection
- •Allergy to CT-P13
结局指标
主要结局
Development of anti-drug antibody to CT-P13
时间窗: one year
次要结局
- Change of drug trough concentration(one year)
研究者
Eun Soo Kim, MD, PhD
Professor
Kyungpook National University Hospital
研究点 (1)
Loading locations...
相似试验
招募中
不适用
Occurrence of Anti-drug antibody and change of drug level for 1 year after CT-P13 therapy and their Impact on clinical outcomes in moderate to Severe inflammatory bowel diseaseKCT0002222Kangbuk Samsung Medical Center300
已完成
不适用
Drug Concentration, Immunogenicity, and Efficacy Study in Patients With Rheumatoid Arthritis Currently Treated With Etanercept, Adalimumab, or InfliximabRheumatoid ArthritisNCT01981473Pfizer605
已完成
不适用
ADAs to AlemtuzumabMultiple SclerosisNCT06310343Queen Mary University of London15
Unknown
不适用
Study of Antibodies to Anti-TNF Agents in Juvenile Idiopathic ArthritisJuvenile Idiopathic ArthritisNCT01436019Blood Transfusion Centre of Slovenia100
已完成
不适用
A Prospective Trial to Study the Evolution of Clonal Architecture of Tumors From Patients Treated With Molecular Targeted AgentsMetastatic Oncogen-driven CancerNCT02517892Gustave Roussy, Cancer Campus, Grand Paris1,500