Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 262
- 试验地点
- 1
- 主要终点
- Percentage of patients continuing INFLECTRA®
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition
详细描述
All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months will be invited to continue to receive infliximab but using its biosimilar (INFLECTRA®)) at the same regimen (identical dose per infusion and interval between two infusions) than the previous one while receiving REMICADE®. The tolerability of the infusion will be recorded as well as the percentage of patients continuing INFLECTRA® after at least six months of its initiation.
Moreover, the infliximab serum level will be evaluated after the last infusion of REMICADE® and after the third infusion of INFLECTRA®. At the same time, anti-drug antibodies will be tested.
Finally for each of the underlying disease (e.g. rheumatoid arthritis, spondyloarthritis, Crohn's disease, uveitis,..), the maintenance of the efficacy of Infliximab will be evaluated according to the usual outcome measures of the activity of the disease
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female over 18 year old
- •Patient treated with REMICADE® in Cochin hospital
- •More than 3 perfusions of REMICADE® before the switch to INFLECTRA®
排除标准
- 未提供
结局指标
主要结局
Percentage of patients continuing INFLECTRA®
时间窗: after the third infusion of INFLECTRA®, up to 24 weeks
Evaluation of the percentage of patients continuing INFLECTRA® after its third infusion
次要结局
- Infliximab serum level(after the third infusion of INFLECTRA®, up to 24 weeks)
- Percentage of patients with a flare of their disease(after the third infusion of INFLECTRA®, up to 24 weeks)
- Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®(after the third infusion of INFLECTRA®, up to 24 weeks)
- Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®(after the last infusion of REMICADE®, up to 24 weeks)