Authorised Therapeutic use (Phase IV) Acute severe ulcerative colitis

Model-informed precision dosing during infliximab rescue therapy for patients with steroid-refractory acute severe ulcerative colitis: an exploratory study (the IGNITE study)

EU CTIS ID: 2023-503509-12-00

What this study is testing

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]

  • Therapeutic use (Phase IV)

A plain-language read of the study's public EU CTIS listing. The study team confirms the details.

Who can take part

You may be able to join if

  • 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.

You likely can't join if

  • The subject has an ostomy or an ileal pouch anal anastomosis.
  • The subject received ciclosporin prior to infliximab as rescue therapy during the same hospitalisation.
  • The subject is participating in another interventional clinical trial.
See the full eligibility criteria
Who can join
  • 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.
What rules you out
  • The subject has an ostomy or an ileal pouch anal anastomosis.
  • The subject received ciclosporin prior to infliximab as rescue therapy during the same hospitalisation.
  • The subject is participating in another interventional clinical trial.

The study team makes the final eligibility decision.

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.

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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.