Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT04990258
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-24
First Post:
2021-06-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
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
Sponsor:
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Organization:
Study Overview
Official Title:
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
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEREM
Brief Summary:
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.
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:
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
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
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: