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

Study Overview
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Brief Summary
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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.

Detailed Description
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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

Official Title
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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

Conditions
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Inflammatory Bowel Diseases

Intervention / Treatment
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* Drug: Subcutaneous infliximab CT-P13 Remsima®SC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Subcutaneous infliximab CT-P13 Remsima®SC|Patients will be switched from IV infliximab into subcutaneous infliximab Remsima®SC 120 mg.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subcutaneous infliximab dosage after switch | 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. | Month 12 | 
| Efficacy of Subcutaneous infliximab treatment in clinical remission | Steroid-free clinical remission 24 months after switching | Month 24 | 
| Safety of subcutaneous infliximab treatment | Proportion of participants with treatment-related adverse events for a period of 24 months after switching | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio efficacy of SC Infliximab in clinical remission | Percentage of patients on steroid free clinical remission at month 24 after switch. Steroid-free Clinical Remission (CR) is defined 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. When HBI scoring will not be feasible (stoma, pouch), evaluation of clinical remission will be estimated by physician global assessment. Patients having discontinued subcutaneous infliximab therapy whatever the reason during the 12 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 subcutaneous infliximab Remsima®SC during the whole study period | Month 24 | 
| Loss of response to infliximab SC treatment | Percentage of patients who switch back to originator previous therapy IV infliximab at month 12 after switching from IV infliximab to SC infliximab Remsima®SC in IBD patient | Month 12 | 
| Efficacy of SC Infliximab treatment on patient quality of life | Percentage of PRO2 response and remission at month 12 | Month 12 | 
| Efficacy of SC Infliximab treatment in biological remission | Percentage of biological remission rates (FC <250 μg/g, CRP <5 mg/L) at month 12 | Month 12 | 
| Efficacy of SC Infliximab treatment in preventing relapse | Percentage of clinical relapse free rates at month 12. | Month 12 | 
| Efficacy of SC Infliximab treatment in preventing loss of respone | Percentage of loss of response rates at month 12 | Month 12 | 
| Loss of clinical response | Percentage of clinical response and remission at month 3 | Month 3 | 
| Disease activity | Mean change from baseline in For Crohn Disease: HBI( Harvey Bradshaw Index): For Ulcerative Colitis: PMS ( Partial mayo score) Biological criteria CRP (mg/l): Remission < 5 mg CRP in 1 litre of blood and fecal calprotectin ( μg/g ) : Remission < 250 μg of fecal calprotectin in 1 g of stool HBI score, PMS score, CRP and Calprotectin feacal will be combined to report the disease activity (this outcome is is expressed without units) | Month 24 | 
| Treatment adherence | Proportion of patients with positive antibodies (IFX, ADA) comparing therapy with original and SC infliximab. | Month 24 | 
| Medication Possession Ratio (MPR) | Adherence to biosimilar switch during the follow-up: MPR ratios. | Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD UC