Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT05552287 Sponsor: Erasmus Medical Center Condition: Crohn's Disease and Colitis
Back to Crohns Disease And Colitis

Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT05552287
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Children aged 1 to 15 years who have been diagnosed with Crohn's disease and have never previously been treated with a type of medication called anti-TNF therapy
  • Children whose doctors have decided they need to start a treatment called infliximab (IFX), for example because other treatments like special liquid diets, steroids, or immune-suppressing medicines have not worked well enough
  • Children with Crohn's disease that is severe, widespread, causing poor growth, or affecting areas in and around the bowel in complicated ways, as judged by their doctor

Who may not be able to join:

  • Children whose inflammatory bowel disease (IBD) is caused by a single known gene change (monogenetic IBD)
  • Children diagnosed with ulcerative colitis or a form of IBD that has not been clearly defined (IBD-U), or a condition that looks like ulcerative colitis
  • Children who currently have active fistulas or active disease around the anal area at the time of starting infliximab (children with inactive fistulas or perianal disease may still be eligible)
  • Children with serious health conditions unrelated to their bowel disease
  • Children who urgently need surgery due to a narrowing or blockage in the bowel
  • Children who have a serious infection such as blood poisoning, certain rare infections, signs of tuberculosis on a skin test or chest X-ray, or cancer
  • Children who are pregnant or possibly pregnant
  • Children who have previously been treated with infliximab, any other anti-TNF medication, or any other biological drug
  • Children who started steroid or mesalazine treatment less than 2 weeks before their first infliximab infusion
  • Children who started a special liquid-only diet (exclusive enteral nutrition) less than 2 weeks before their first infliximab infusion

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Lissy de Ridder, PhD, Erasmus Medical Center - Sophia Children's Hospital

Phone: 0107036076

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Erasmus Medical Center
Registry
ClinicalTrials.gov
Start date
2 August 2023
Est. completion
1 August 2025

Where this trial is recruiting

🇳🇱 Netherlands

Primary endpoints

Proportion of patients with IFX Trough Levels ≥ 5 µg/mL at week 12 without treatment escalation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov