An observational study in Inflammatory Bowel Diseases, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Active, not recruiting at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-01-24.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Observational
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.
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:
1,460 studies on the registry are indexed under Inflammatory Bowel Diseases; 437 are open to participants now.
This study's enrollment of 444 is above the median of 139 across 645 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives is the lead sponsor of 35 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Age ≥ 18 ans, CD patients (HBI ≤4) or UC patients (PMS ≤2) with established diagnosis > 6 months treated with Infliximab IV, agreeing to switch from IV to SC formulation or who have just switched to subcutaneous infliximab Remsima®SC as part of routine care
Male or female subjects who are more than 18 years of age, on the day of signing informed consent.
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).
Exclusion Criteria:
Patients will be switched from IV infliximab into subcutaneous infliximab Remsima®SC 120 mg.
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.
Time frame: Month 12
Efficacy of Subcutaneous infliximab treatment in clinical remission
Steroid-free clinical remission 24 months after switching
Time frame: Month 24
Safety of subcutaneous infliximab treatment
Proportion of participants with treatment-related adverse events for a period of 24 months after switching
Time frame: Month 24
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
Time frame: 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
Time frame: Month 12
Efficacy of SC Infliximab treatment on patient quality of life
Percentage of PRO2 response and remission at month 12
Time frame: 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
Time frame: Month 12
Efficacy of SC Infliximab treatment in preventing relapse
Percentage of clinical relapse free rates at month 12.
Time frame: Month 12
Efficacy of SC Infliximab treatment in preventing loss of respone
Percentage of loss of response rates at month 12
Time frame: Month 12
Loss of clinical response
Percentage of clinical response and remission at month 3
Time frame: 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)
Time frame: Month 24
Treatment adherence
Proportion of patients with positive antibodies (IFX, ADA) comparing therapy with original and SC infliximab.
Time frame: Month 24
Medication Possession Ratio (MPR)
Adherence to biosimilar switch during the follow-up: MPR ratios.
Time frame: Month 24
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives