PERFUSE - One-year Persistence to Treatment of Patients Receiving Flixabi or Imraldi: a French Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 2,274
- 试验地点
- 11
- 主要终点
- Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months
研究概览
简要总结
A study to describe the one-year persistence in participants treated by Flixabi (infliximab) or Imraldi (Adalimumab) as prescribed by the physician for each of the 5 following indications: Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Psoriatic Arthritis (PsA), Crohn's Disease (CD) [adults and children] and Ulcerative Colitis (UC) [adults for both treatments and children only for Flixabi].
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participant (18 years and over)
- •treated for one of the following conditions: RA, AS, PsA, CD, UC.
- •either active substance naïve or treated with the originator or another biosimilar at baseline.
- •for whom the treating physician has decided to treat by (naïve) or switch from originator or another biosimilar to Flixabi or Imraldi.
- •participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.
- •Paediatric participants (6-17 years):
- •treated for one of the following conditions: CD, UC.
- •either active substance naïve or treated with another biosimilar at baseline.
- •for whom the treating physician has decided to treat by (naïve) or switch to Flixabi (for both indications) or Imraldi (only for Crohn's disease).
- •participants who had initiated Flixabi or Imraldi at most 12 months before the baseline will also be included in the cohort.
排除标准
- •Participant treated for psoriasis.
- •Participant who are not to be followed up in the same investigator site for 2 years after baseline.
- •NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Flixabi
Infliximab naive participants or participants who were previously treated with other infliximab biologics will receive Flixabi (infliximab) as prescribed by physician according to the local prescribing procedures.
干预措施: Infliximab (Drug)
Imraldi
Adalimumab naive participants or participants who were previously treated with other adalimumab biosimilars will receive Imraldi (adalimumab) as prescribed by physician according to the local prescribing procedures.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Percentage of Participants who are Still Treated with Either Flixabi or Imraldi at 12 Months
时间窗: Up to 12 months
Percentage of participants, either infliximab naïve or switched from Remicade or CT-P13 to Flixabi, who are still treated with Flixabi, and either adalimumab naïve or switched from Humira or other adalimumab biosimilars to Imraldi, who are still treated with Imraldi, at 12 months for RA, AS, PsA, CD (adults and children), and UC (adults for both treatments and children only for Flixabi) will be reported.
次要结局
未报告次要终点