NCT04982172

Model-informed Dose De-escalation of Infliximab in Patients With Inflammatory Bowel Diseases

Model-informed Infliximab Dose De-escalation Following Earlier Dose Escalation in Adult Patients With Inflammatory Bowel Diseases

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a monocentric, two-arm, non-randomised, non-blinded, historically controlled, interventional trial. The purpose of this trial is to investigate the effect of model-informed infliximab dose de-escalation on the infliximab exposure and therapeutic outcome as compared to standard dose de-escalation in patients with inflammatory bowel diseases.

Conditions

• Inflammatory Bowel Diseases

Interventions

Type	Name	Description
DRUG	Infliximab	Infliximab (Inflectra® \[Pfizer\]), dosage determined using model-informed precision dosing, intravenously administered
DRUG	Infliximab	Infliximab, dosage following a dose de-escalation algorithm at the physician's discretion, intravenously administered

Timeline

• Start date: 2022-02-08
• Primary completion: 2022-11-01
• Completion: 2023-02-01
• First posted: 2021-07-29
• Last updated: 2024-12-11

Locations

1 site across 1 country: Belgium