A 24-month Real Life PErsistence Efficacy and Safety Study in IBD Patients in REMission Switched From Intravenous Infliximab to Subcutaneous Infliximab CT-P13 Remsima®SC
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 444
- 试验地点
- 1
- 主要终点
- Efficacy of Subcutaneous infliximab treatment in clinical remission
研究概览
简要总结
Descriptive: A 24-month multicentre, observational, prospective cohort study. Population: IBD Patients under stable clinical and biological remission Study treatments: Patients who will be proposed to switch, or who have just switched, from the intravenous originator Remicade® or one of its biosimilars to the subcutaneous infliximab Remsima®SC as part of routine care. All consecutive patients in IBD centers participating in the study will be proposed to participate in the study during their regular outpatients' visits.
Objectives:The primary objective of PEREM study is to determine the rate of persistence of subcutaneous infliximab at 48 weeks after switching from IV infliximab to subcutaneous infliximab Remsima®SC.
详细描述
Number of patients: 400 patients in approximatively 40 sites in France Recrutment period: The trial duration for each patient will be 2 years Main Endpoint:The primary endpoint is to assess the rate of persistence of subcutaneous infliximab at month 12 after switching from IV infliximab to SC infliximab Remsima®SC.
Secondary Endpoint:
- Percentage of patients on steroid free clinical remission at week 96 after switch. Steroid-free Clinical Remission (CR) is defined as a Harvey Bradshaw Index (HBI) score≤4 CD patients and a Partial Mayo Score (PMS) ≤2 with each sub-score of 1 or less for UC. When HBI scoring will be infeasible (stoma, pouch), evaluation of clinical remission will be estimated by stoma emptying count and/or by the physician global assessment (Sturm 2019) Patients having discontinued subcutaneous infliximab Remsima®SC therapy whatever the reason during the 24 months of follow-up as well as patients referred to disease-related surgery and patients lost to follow-up before month 24 will be considered as failure to subcutaneous infliximab Remsima®SC therapy (intention to treat analysis) and will be classified in the group of patients having failed to maintain steroid free clinical remission under infliximab Remsima®SC during the whole study period.
- Percentage of patient Reported Outcomes PRO2 rates at inclusion, months 3, 6, 12 and 24
- Percentage of biological remission rates (FC <250 μg/g, CRP <5 mg/L) at inclusion, month 3, 6, 12 and 24.
- Percentage of clinical relapse free rates at inclusion, month 3, 6, 12 and 24
- Percentage of loss of response rates at inclusion, month 3, 6, 12 and 24
- Percentage of clinical response and remission at inclusion, month 3, 6, 12 and 24
- Mean change from baseline in HBI or PMS, and mean change from baseline in CRP and fecal calprotectin
- Proportion of patients with positive antibodies (IFX, ANA) comparing therapy with intravenous or one of its biosimilars original and subcutaneous infliximab Remsima®SC
- Measure adherence to subcutaneous infliximab Remsima® switch based on pharmacy data during the follow-up with Medication Possession Ratio (MPR ).
- Twelve-month cumulative surgery rates
- Hospitalization rate at month 24
- Cumulative infection rate at month 24
- Cumulative SC reactions at month 24
- Discontinuation of subcutaneous infliximab therapy cumulative rates at month 24
- Incidence of specific anti-drug antibodies detected during the study
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •• Male or female subjects who are more than 18 years of age, on the day of signing informed consent.
- •Patient affiliated to the health insurance system.
- •Documented diagnosis of CD or UC established based on standard clinical, endoscopic, and histological criteria.
- •CD or UC remission defined per clinical assessment as a Harvey Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) ≤2 with each sub-score of 1 or less for UC and/or according to ECCO classification within previous 6 months.
- •Currently treated with IV infliximab: originator or biosimilars.
- •Patients agreeing to switch from IV to SC formulation or who have already switched since maximum 3 months.
- •Receiving or not the concomitant following drugs (but must remain on stable dose for 12 weeks):
- •Oral 5-aminosalicylates (5ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching.
- •Azathioprine, 6-MP or methotrexate provided the dose has been stable for 4 weeks prior to inclusion (dose must remain stable for 10 weeks after switching).
- •Each patient is required to provide written informed consent to be included in the study.
排除标准
- •Current use of vedolizumab or ustekinumab
- •Current use of JAK inhibitors or S1P modulators
- •Current use of steroids or within the last three months for IBD
- •Treatment with any investigational agent in the past 30 days or five half-lives prior to the inclusion visit
- •Current CD abscess
- •Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis
- •Female subjects with pregnancy or breastfeeding
结局指标
主要结局
Efficacy of Subcutaneous infliximab treatment in clinical remission
时间窗: Month 24
Steroid-free clinical remission 24 months after switching
Subcutaneous infliximab dosage after switch
时间窗: Month 12
To describe subcutaneous infliximab persistence after the switch from IV infliximab originator Remicade® or one of its biosimilars to SC infliximab (Remsima®SC) at month 12.
Safety of subcutaneous infliximab treatment
时间窗: Month 24
Proportion of participants with treatment-related adverse events for a period of 24 months after switching
次要结局
- Loss of clinical response(Month 3)
- Ratio efficacy of SC Infliximab in clinical remission(Month 24)
- Efficacy of SC Infliximab treatment in preventing relapse(Month 12)
- Efficacy of SC Infliximab treatment in preventing loss of respone(Month 12)
- Medication Possession Ratio (MPR)(Month 24)
- Loss of response to infliximab SC treatment(Month 12)
- Efficacy of SC Infliximab treatment on patient quality of life(Month 12)
- Treatment adherence(Month 24)
- Efficacy of SC Infliximab treatment in biological remission(Month 12)
- Disease activity(Month 24)