{"ctNumber":"2024-510718-34-00","ctStatus":"Authorised","startDateEU":"2024-11-29","decisionDate":"2024-09-09T17:19:59.143","publishDate":"2026-02-21T02:41:51.898069591","ctPublicStatusCode":4,"authorizedApplication":{"authorizedPartI":{"id":115429,"rowSubjectCount":0,"products":[{"id":478941,"part1MpRoleTypeCode":"1","productDictionaryInfo":{"productPk":"10780441","productPharmForm":"CONCENTRATE FOR SOLUTION FOR INFUSION","euMpNumber":"PRD4797328","marketingAuthNumber":"EU/1/16/1167/001","prodAuthStatus":2,"prodName":"Truxima 500 mg concentrate for solution for infusion","pharmForm":"SOLUTION FOR INFUSION","activeSubstanceName":"RITUXIMAB","euSubstNumber":"SUB12570MIG","authorisationCountryCode":"EU","mrpNumber":"EMEA/H/C/004112","nameOrg":"CELLTRION HEALTHCARE HUNGARY KFT","productSubstances":[{"productPk":"10780441","substancePk":"335267","nameOrg":"CELLTRION HEALTHCARE HUNGARY KFT","substanceOrigin":"Protein - Other","actSubstOrigin":"Protein - Other","actSubstName":"RITUXIMAB","substanceEvCode":"SUB12570MIG"}],"atcCode":"L01FA01","atcName":"-","atcTermLevel":"5","activeSubstanceOtherDescriptiveName":""},"isPaediatricFormulation":false,"mpRoleInTrial":"1","orphanDrugEdit":false,"doseUom":"g gram(s)","maxDailyDoseAmount":"1","doseUomTotal":"g gram(s)","maxTotalDoseAmount":"4","productChangedRelationMA":false,"maxTreatmentPeriod":45,"timeUnitCode":"1","evCode":"PRD4797328","devices":[],"characteristics":[],"routes":["INTRAVENIOUS INFUSION"],"allSubstancesChemicals":false,"productName":"Truxima 500 mg concentrate for solution for infusion","jsonActiveSubstanceNames":"rituximab","pharmaceuticalFormDisplay":"SOLUTION FOR INFUSION"}],"trialDetails":{"clinicalTrialIdentifiers":{"fullTitle":"Study of Artificial Intelligence-based Personalized Rituximab Treatment Protocol in Membranous nephropathy","fullTitleTranslations":[{"id":9447588,"uuid":"dfb3280e-9d56-4e91-b75e-b1260949f196","attributeTranslation":"Traitement personnalisé par rituximab basé sur l'intelligence artificielle dans la glomérulonéphrite extra-membraneuse (iRITUX)","language":34,"languageDescription":"French (France)"}],"publicTitle":"Study of Artificial Intelligence-based Personalized Rituximab Treatment Protocol in Membranous nephropathy - iRITUX","publicTitleTranslations":[],"shortTitle":"22-APN-01","secondaryIdentifyingNumbers":{"nctNumber":{"id":479701,"number":"NCT06341205"},"additionalRegistries":[]}},"trialInformation":{"trialCategory":{"isLowIntervention":true,"justificationOfLowIntervention":"Treatment administered according to the French guidelines","trialPhase":"11","trialCategory":"3","justificationForTrialCategory":"Phase III and Phase IV (Integrated)","trialCategoryId":105643},"medicalCondition":{"partIMedicalConditions":[{"id":119888,"medicalCondition":"Membranous nephropathy","medicalConditionTranslations":[{"id":9447556,"uuid":"b2b2d839-b090-4678-8a0e-a6f87d53787c","attributeTranslation":"Glomérulonéphrite extra-membraneuse","language":10,"languageDescription":"French"}],"isConditionRareDisease":true}],"meddraConditionTerms":[{"termId":100000030121,"version":"21.1","level":"LLT","termName":"Acute glomerulonephritis","classificationCode":"10000788","organClass":10038359,"active":false}]},"trialObjective":{"trialScopes":[{"code":"3","trialScopeId":349394}],"mainObjective":"To compare, in nephrotic rituximab-treated membranous nephropathy, the efficacy of a standard-of-care treatment versus a personalized treatment driven by the recommendation of the algorithm that predicts the risk of drug underexposure at month-3, in inducing clinical remission 6 months after rituximab treatment initiation.","mainObjectiveTranslations":[{"id":9447595,"uuid":"01f61c59-9ac9-49af-b1e5-e043c1b49c90","attributeTranslation":"Comparer l’efficacité sur la rémission clinique à 6 mois (M6) entre un traitement par rituximab classique et une prise en charge personnalisée basée sur un algorithme prédictif du risque de sous-exposition au rituximab à 3 mois (M3).","language":34,"languageDescription":"French (France)"}],"secondaryObjectives":[{"id":404993,"number":1,"secondaryObjective":"To compare a personalized treatment of membranous nephropathy driven by the recommendation of the algorithm versus the standard-of-care treatment regarding: 1. 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