Evaluation of the Safety and Effectiveness of Switching From Originator (Humira®) to Biosimilar (Imraldi®) Adalimumab in Flanders (SafE-OrBi)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Adalimumab (ADA) trough level
研究概览
简要总结
This is a multicentre, phase IV, prospective, interventional cohort study to evaluate the safety and effectiveness of switching from Originator (Humira®) to Biosimilar (Imraldi®) adalimumab in routine clinical practice. The study will include approximately 170 patients (100 patients treated in OLV Aalst and 70 patients treated in AZ Maria Middelares Gent). The study collects baseline clinical characteristics and assessment of parameters regarding switch and overall satisfaction. For patients who are willing to switch, there is a 12-month follow-up (study) period. During the follow-up (study) period patients will continue their treatment with adalimumab, i.e. Imraldi®, except if good clinical practice for the patient would oblige the treating physician to change treatment regimen.
详细描述
The physicians and IBD nurses working with IBD patients in the participating centres will be informed by the Principal Investigator (PI) with up-to-date information regarding this trial and regarding biologicals and biosimilars, with a specific emphasis on the data available for Imraldi®. The information will be given at an especially organized meeting for this purpose, which will take about two hours. Only physicians attending this meeting will be able to participate in the study.
All IBD patients with a diagnosis of CD or UC, followed by a physician who attended the meeting and who are currently on maintenance therapy with Humira® for at least 8 weeks, are eligible to be invited to enter the study. The acceptance rate will be measured at baseline as the proportion of patients who accept the switch among all patients.
In the outpatient clinic, the subject of switching from Humira® to Imraldi® can be discussed with the patient. All patients on Humira® will be informed about the possibility to switch to Imraldi® and to participate in this trial. Irrespective of their intention to switch, all patients will be offered a standardized evaluation of their current disease status, with - if necessary - adjustment of their therapy. The information is initially given by the treating physician and - if necessary - can be further fine-tuned by the IBD-nurse or physician in consecutive follow-up visits. All patients will be provided with patient information and consent form. Informed consent must be obtained prior to baseline procedures. A unique subject identification number will be assigned to each patient and used throughout the study.
From all included patients (i.e. those agreeing to switch and those declining to switch), baseline clinical characteristics (year of birth, gender, year of IBD diagnosis, previous treatment and previous surgery, smoking status, Montreal Classification, co-immunomodulatory drug use and corticoid co-administration), Humira® treatment details and visual analogue scale assessment of parameters regarding switch and overall satisfaction with current treatment, will be collected.
From the patients willing to switch, prospective data on effectiveness and safety and subjective satisfaction on different aspects of Imraldi® use, will be obtained at 3 predefined timepoints: 8 weeks, 6 and 12 months after switch to Imraldi®.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult (≥ 18 years of age).
- •Ulcerative Colitis or Crohn's disease diagnosis.
- •Maintenance therapy with Humira® for at least 8 weeks prior to switch to Imraldi®.
- •Able to communicate in Flemish or French or English.
- •Able and willing to voluntarily participate in the study and to provide signed informed consent.
排除标准
- •Currently included in an interventional study.
- •Pregnant or breastfeeding.
研究组 & 干预措施
single arm
Adult patients (≥ 18 years of age) with Ulcerative Colitis or Crohn's Disease on maintenance therapy with Humira® for at least 8 weeks prior to switch to Imraldi®.
干预措施: single arm (Drug)
结局指标
主要结局
Adalimumab (ADA) trough level
时间窗: from Imraldi initiation (baseline) until month 12
Change from baseline in adalimumab (ADA) through level at month 12
次要结局
- Adalimumab (ADA) trough level(from Imraldi initiation (baseline) until month 6)
- Association of adalimumab (ADA) trough level with clinical outcome (Secundary loss of Response (SLOR)(From Imraldi initiation (baseline) until Month 12)
- Physician Global Assessment (PGA)(From Imraldi initiation (baseline) until Month 12)
- C-Reactive protein (CRP)(From Imraldi initiation (baseline) until Month 12)
- Number of patients still treated with Imraldi®(at Week 8, Month 6 and Month 12)
- Clinical mayo score(From Imraldi initiation (baseline) until Month 12)
- Patient acceptance of the switch from Humira® to Imraldi® measured by Visual Analogue Scale (VAS)(Single score at Month 6)
- Visual Analogue Scale (VAS) to measure patient satisfaction with biologic treatment(From Imraldi initiation (baseline) until Month 12)
- Disease activity scores (Crohn's Disease Activity Index (CDAI) )(From Imraldi initiation (baseline) until Month 12)
- faecal calprotectin(From Imraldi initiation (baseline) until Month 12)
- leucocyte count(From Imraldi initiation (baseline) until Month 12)
- Adverse Events with a possible/probable causal relationship to adalimumab(From Imraldi initiation (baseline) until Month 12)
- Serious Adverse Events(From Imraldi initiation (baseline) until Month 12)
- Number of patients who discontinued Imraldi® due to loss of effectiveness, adverse event, presence of anti-ADA antibodies or patient/physician decision.(From Imraldi initiation (baseline) until Month 12)
研究者
Pieter Dewint, MD PhD
Coordinating Investigator
Algemeen Ziekenhuis Maria Middelares