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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 444}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-01-23', 'studyFirstSubmitDate': '2021-06-14', 'studyFirstSubmitQcDate': '2021-08-03', 'lastUpdatePostDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Subcutaneous infliximab dosage after switch', 'timeFrame': 'Month 12', 'description': '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.'}, {'measure': 'Efficacy of Subcutaneous infliximab treatment in clinical remission', 'timeFrame': 'Month 24', 'description': 'Steroid-free clinical remission 24 months after switching'}, {'measure': 'Safety of subcutaneous infliximab treatment', 'timeFrame': 'Month 24', 'description': 'Proportion of participants with treatment-related adverse events for a period of 24 months after switching'}], 'secondaryOutcomes': [{'measure': 'Ratio efficacy of SC Infliximab in clinical remission', 'timeFrame': 'Month 24', 'description': 'Percentage of patients on steroid free clinical remission at month 24 after switch.\n\n* 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.\n* When HBI scoring will not be feasible (stoma, pouch), evaluation of clinical remission will be estimated by physician global assessment.\n* 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'}, {'measure': 'Loss of response to infliximab SC treatment', 'timeFrame': 'Month 12', 'description': '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'}, {'measure': 'Efficacy of SC Infliximab treatment on patient quality of life', 'timeFrame': 'Month 12', 'description': 'Percentage of PRO2 response and remission at month 12'}, {'measure': 'Efficacy of SC Infliximab treatment in biological remission', 'timeFrame': 'Month 12', 'description': 'Percentage of biological remission rates (FC \\<250 μg/g, CRP \\<5 mg/L) at month 12'}, {'measure': 'Efficacy of SC Infliximab treatment in preventing relapse', 'timeFrame': 'Month 12', 'description': 'Percentage of clinical relapse free rates at month 12.'}, {'measure': 'Efficacy of SC Infliximab treatment in preventing loss of respone', 'timeFrame': 'Month 12', 'description': 'Percentage of loss of response rates at month 12'}, {'measure': 'Loss of clinical response', 'timeFrame': 'Month 3', 'description': 'Percentage of clinical response and remission at month 3'}, {'measure': 'Disease activity', 'timeFrame': 'Month 24', 'description': 'Mean change from baseline in\n\n* For Crohn Disease: HBI( Harvey Bradshaw Index):\n* For Ulcerative Colitis: PMS ( Partial mayo score)\n* Biological criteria\n\n * CRP (mg/l): Remission \\< 5 mg CRP in 1 litre of blood and\n * fecal calprotectin ( μg/g ) : Remission \\< 250 μg of fecal calprotectin in 1 g of stool\n\nHBI score, PMS score, CRP and Calprotectin feacal will be combined to report the disease activity (this outcome is is expressed without units)'}, {'measure': 'Treatment adherence', 'timeFrame': 'Month 24', 'description': 'Proportion of patients with positive antibodies (IFX, ADA) comparing therapy with original and SC infliximab.'}, {'measure': 'Medication Possession Ratio (MPR)', 'timeFrame': 'Month 24', 'description': 'Adherence to biosimilar switch during the follow-up: MPR ratios.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['IBD UC'], 'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': "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.\n\nObjectives: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.", 'detailedDescription': '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.\n\nSecondary Endpoint:\n\n* 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.\n* Percentage of patient Reported Outcomes PRO2 rates at inclusion, months 3, 6, 12 and 24\n* Percentage of biological remission rates (FC \\<250 μg/g, CRP \\<5 mg/L) at inclusion, month 3, 6, 12 and 24.\n* Percentage of clinical relapse free rates at inclusion, month 3, 6, 12 and 24\n* Percentage of loss of response rates at inclusion, month 3, 6, 12 and 24\n* Percentage of clinical response and remission at inclusion, month 3, 6, 12 and 24\n* Mean change from baseline in HBI or PMS, and mean change from baseline in CRP and fecal calprotectin\n* Proportion of patients with positive antibodies (IFX, ANA) comparing therapy with intravenous or one of its biosimilars original and subcutaneous infliximab Remsima®SC\n* Measure adherence to subcutaneous infliximab Remsima® switch based on pharmacy data during the follow-up with Medication Possession Ratio (MPR ).\n* Twelve-month cumulative surgery rates\n* Hospitalization rate at month 24\n* Cumulative infection rate at month 24\n* Cumulative SC reactions at month 24\n* Discontinuation of subcutaneous infliximab therapy cumulative rates at month 24\n* Incidence of specific anti-drug antibodies detected during the study'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* • Male or female subjects who are more than 18 years of age, on the day of signing informed consent.\n\n * Patient affiliated to the health insurance system.\n * Documented diagnosis of CD or UC established based on standard clinical, endoscopic, and histological criteria.\n * 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.\n * Currently treated with IV infliximab: originator or biosimilars.\n * Patients agreeing to switch from IV to SC formulation or who have already switched since maximum 3 months.\n * Receiving or not the concomitant following drugs (but must remain on stable dose for 12 weeks):\n* Oral 5-aminosalicylates (5ASA) compounds or rectal formulations of 5ASA provided the dose to be stable at least 4 weeks before switching.\n* 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).\n\n * Each patient is required to provide written informed consent to be included in the study.\n\nExclusion Criteria:\n\n* Current use of vedolizumab or ustekinumab\n* Current use of JAK inhibitors or S1P modulators\n* Current use of steroids or within the last three months for IBD\n* Treatment with any investigational agent in the past 30 days or five half-lives prior to the inclusion visit\n* Current CD abscess\n* Active clinically significant infection or HIV, Hep B, Hep C, untreated tuberculosis\n* Female subjects with pregnancy or breastfeeding'}, 'identificationModule': {'nctId': 'NCT04990258', 'acronym': 'PEREM', 'briefTitle': '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', 'organization': {'class': 'OTHER', 'fullName': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'GT-2021-02'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Subcutaneous infliximab CT-P13 Remsima®SC', 'type': 'DRUG', 'description': 'Patients will be switched from IV infliximab into subcutaneous infliximab Remsima®SC 120 mg.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Nicolas Mathieu', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives", 'class': 'OTHER'}, 'collaborators': [{'name': 'Celltrion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}