Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study (the IGNITE study)
Key facts
- Where
- Leuven, BelgiumSee the site
- Phase
- 4. fázis
Where in Belgium
- UZ LeuvenLeuven, BelgiumTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- UZ Leuven
- Trial code
- EU 2023-503509-12-00
- Record updated
- 2026. augusztus 11.
- Original description
• 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]Read full original descriptionShow less
Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study
• 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]
Inclusion: 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.
Exclusion: 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.