Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06381518
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-24
First Post:
2024-03-12
Brief Title:
Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease
Sponsor:
Zuyderland Medisch Centrum
Organization:
Zuyderland Medisch Centrum
Study Overview
Official Title:
Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease Evaluation of Exposure Parameters
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SHUFFLE
Brief Summary:
The aim of this study is to evaluate the IFX exposure AUC effectiveness presence of ADAbs and treatment burden before and after switching from IV to SC IFX maintenance treatment in a real-world cohort of IBD patients with quiescent disease on IFX monotherapy and combination therapy of IFX and an immunomodulator
Methods this is a prospective single centre open-label cohort study conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX cohort 2 After the switch to SC CT-P13 patients are followed for 24 weeks
The study is subdivided into two phases the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch After enrolment the subject receives a final dose of IV IFX according to their own maintenance schedule Primary endpoints are the Area under the concentration-time curve AUC at steady state 1 before and after the switch to SC CT-P13 and 2 with or without concomitant immunomodulator during SC therapy AUCs will be estimated using pharmacokinetic modelling in MwPharm Besides IFX trough level treatment related time expenditure quality-of-life and patient satisfaction will be assessed before and after the switch
Methods this is a prospective single centre open-label cohort study conducted in Zuyderland Medical Centre in which 36 adult IBD patients in remission on stable IV IFX therapy are switched to SC CT-P13 of which 18 patients use an immunomodulator in addition to IFX cohort 2 After the switch to SC CT-P13 patients are followed for 24 weeks
The study is subdivided into two phases the IV IFX treatment phase before switching and the SC CT-P13 treatment phase after the switch After enrolment the subject receives a final dose of IV IFX according to their own maintenance schedule Primary endpoints are the Area under the concentration-time curve AUC at steady state 1 before and after the switch to SC CT-P13 and 2 with or without concomitant immunomodulator during SC therapy AUCs will be estimated using pharmacokinetic modelling in MwPharm Besides IFX trough level treatment related time expenditure quality-of-life and patient satisfaction will be assessed before and after the switch
Detailed Description:
On demand
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None