MedTrace Logo

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

NCT04982172 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2024-12-11

No results posted yet for this study

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

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

Sponsors & Collaborators

  • KU Leuven

    collaborator OTHER

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Marc Ferrante, MD, PhD · UZ Leuven

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-08
Primary Completion
2022-11-01
Completion
2023-02-01

Countries

  • Belgium

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04982172 on ClinicalTrials.gov