MedTrace Logo

TITRATE (inducTIon for acuTe ulceRATivE Colitis)

NCT03937609 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2025-02-06

No results posted yet for this study

Summary

The aim of this study is to investigate whether intensive, personalized IFX dosing by using a pharmacokinetics driven dashboard system during the induction phase in patients with acute severe UC leads to increased treatment success (as defined by clinical and endoscopic response at week 6) as compared to the standard dosing.

Conditions

  • Colitis, Ulcerative

Interventions

DRUG

Infliximab

infliximab iv 5mg/kg

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

    lead OTHER

Principal Investigators

  • Geert DHaens · Amsterdamumc location AMC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-04
Primary Completion
2024-12-15
Completion
2024-12-15

Countries

  • Ireland
  • Netherlands
  • Norway

Study Locations

More Related Trials

Entities

Drugs
Companies

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 NCT03937609 on ClinicalTrials.gov