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Taking people in BelgiumPhase 4

Adjusting infliximab doses for patients with severe ulcerative colitis

Tests model-guided infliximab dosing in adults with severe ulcerative colitis not responding to steroids.

Key facts

Who runs it
UZ Leuven
Where
Leuven, BelgiumSee the site
Registry title
Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study (the IGNITE study)
Status
Recruiting
Phase
Phase 4
People taking part
13 people, planned
Started
1 Sept 2025
Expected to end
31 Dec 2026
Type of study
Interventional
Record updated
11 August 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults in hospital with acute severe ulcerative colitis. Steroids through a vein did not work, and they are starting infliximab as rescue treatment.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Acute severe ulcerative colitis, known ulcerative colitis confirmed on pathology, admitted to hospital. Steroids through a vein failed (more than 8 stools a day, or 3-8 stools a day with CRP ≥45, and a Lichtiger score ≥ 10 on day 3 (± 2 days)).
Earlier treatment
Must have received no anti-tumour necrosis factor therapy before. Steroids through a vein must have failed. Infliximab is given as rescue treatment for this episode, first dose or already a first dose of 10 mg/kg within the last 48 hours.

Main reasons for not taking part

  • Has an ostomy or an ileal pouch anal anastomosis
  • Received ciclosporin before infliximab rescue treatment during the same hospital stay
  • Is taking part in another interventional clinical trial

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • The subject or, when applicable, the subject's legally acceptable representative signs and dates a written informed consent form and any required privacy authorisation prior to or within 48 hours after the initiation of any study procedures
  • The subject will receive a first dose of infliximab, or already received a first dose of 10 mg/kg infliximab within 48 hours before screening and signing the patient consent form (must have blood samples during each day), as rescue therapy for this episode of ASUC
  • The subject is known with ulcerative colitis and diagnosis confirmed on pathology
  • The subject is aged 18 years to 75 years (inclusive) at the first infliximab infusion
  • The subject has a good understanding of the Dutch and/or English language
  • The subject is admitted with a diagnosis of ASUC defined according to the Truelove and Witts’ criteria
  • The subject is hospitalised
  • The subject failed intravenous steroid treatment as defined by the Oxford criteria (more than 8 stools/d or 3-8 stools/d and CRP ≥45) and a Lichtiger score ≥ 10 on day 3 (± 2 days) after starting intravenous steroid treatment
  • The subject did not receive anti-tumour necrosis factor therapy before
  • The subject will receive infliximab as rescue therapy for this episode of acute severe ulcerative colitis

Who cannot take part

  • The subject received ciclosporin prior to infliximab as rescue therapy during the same hospitalisation
  • The subject has an ostomy or an ileal pouch anal anastomosis
  • The subject is participating in another interventional clinical trial

Where in Belgium

  • UZ LeuvenLeuven, BelgiumTaking people

About the trial

What the trial wants to find out

• To explore/describe the clinical feasibility of implementing MIPD of infliximab therapy for treating patients with ASUC. [feasibility] • To explore/describe the accuracy (lack of bias, and precision) of implementing MIPD of infliximab in patients with ASUC. [performance] • To explore/describe the attainment (including classification accuracy) of (i) the infliximab trough concentration targets and (ii) the model-predicted area under the infliximab concentration-time curve target. [performance]

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record

Print a page for my doctor

Data and sources

Registry record
Listed on the EU's official list of trials (CTIS).
Official title
Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study
Plain-language title
Adjusting infliximab doses for patients with severe ulcerative colitisGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 9 November 2026.
Record updated
11 August 2026