Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 12:08 AM
NCT ID:
NCT04990258
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.
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
Study:
NCT04990258
Study Brief:
Protocol Section:
NCT04990258