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 — PEREM  

Inflammatory Bowel Diseases Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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 ;

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases

• NCT number: NCT04990258
• Study type: Observational
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Status: Active, not recruiting
• Start date: September 6, 2021
• Completion date: September 30, 2024