2023-503509-12-00RecruitingPhase 4
Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study (the IGNITE study)
Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study
Source: EU CTIS (euclinicaltrials.eu) · Last updated 11 Aug 2026
Brief summary (registry, in English)
• 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]
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 13 (estimated)
- First submitted
- 30 Sept 2024
- Start date
- 1 Sept 2025
- Lead sponsor
- UZ Leuven
- Diseases
- Ulcerative colitis
- EU CT number
- 2023-503509-12-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 13
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- The subject received ciclosporin prior to infliximab as rescue therapy during the same hospitalisation.
Other
- The subject has an ostomy or an ileal pouch anal anastomosis.
- The subject is participating in another interventional clinical trial.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UZ Leuven | Leuven | Belgium | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.