Inflammatory Bowel Diseases
Conditions
Keywords
IBD UC
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
Interventions
Patients will be switched from IV infliximab into subcutaneous infliximab Remsima®SC 120 mg.
Sponsors
Celltrion
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subcutaneous infliximab dosage after switch | 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. |
| Efficacy of Subcutaneous infliximab treatment in clinical remission | Month 24 | Steroid-free clinical remission 24 months after switching |
| Safety of subcutaneous infliximab treatment | Month 24 | Proportion of participants with treatment-related adverse events for a period of 24 months after switching |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of SC Infliximab treatment in biological remission | Month 12 | Percentage of biological remission rates (FC \<250 μg/g, CRP \<5 mg/L) at month 12 |
| Efficacy of SC Infliximab treatment in preventing relapse | Month 12 | Percentage of clinical relapse free rates at month 12. |
| Efficacy of SC Infliximab treatment in preventing loss of respone | Month 12 | Percentage of loss of response rates at month 12 |
| Ratio efficacy of SC Infliximab in clinical remission | Month 24 | 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 |
| Disease activity | Month 24 | 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) |
| Treatment adherence | Month 24 | Proportion of patients with positive antibodies (IFX, ADA) comparing therapy with original and SC infliximab. |
| Medication Possession Ratio (MPR) | Month 24 | Adherence to biosimilar switch during the follow-up: MPR ratios. |
| Loss of clinical response | Month 3 | Percentage of clinical response and remission at month 3 |
| Loss of response to infliximab SC treatment | Month 12 | 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 |
| Efficacy of SC Infliximab treatment on patient quality of life | Month 12 | Percentage of PRO2 response and remission at month 12 |
Countries
France
Outcome results
None listed