Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT06113913 Sponsor: Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT06113913
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:

  • You must be willing to take part and have given your written agreement (or have someone legally authorized to do so on your behalf) before any checks are done.
  • You have been previously diagnosed with Crohn's disease, ulcerative colitis, or an unclassified form of inflammatory bowel disease, confirmed through medical tests such as a camera exam of the gut, tissue samples, or scans.
  • You are 18 years old or older.
  • Your bowel disease is currently in remission (well-controlled) without the use of steroids — meaning your symptoms such as bleeding, stool frequency, abdominal pain, and loose stools are at very low levels — and you have not needed steroids for at least the past 8 weeks.
  • Your blood test (CRP) and stool test (calprotectin) results show low levels of inflammation at the time of screening.
  • You have been receiving infliximab through an intravenous (IV) drip for at least 26 weeks in a row.
  • Your IV infliximab dose has stayed the same for at least the past 20 weeks.
  • Your average infliximab dose over 8 weeks (based on your two most recent treatments) is more than 8 mg/kg but no more than 22 mg/kg.
  • You can speak and read Dutch, French, or English fluently.

Who may not be able to join:

  • You are 18 years old or younger.
  • You have had certain bowel surgery, such as a pouch operation or a stoma (ostomy bag).
  • You are currently taking part in another clinical trial involving an experimental medicine or device.
  • You have previously been treated with a subcutaneous (under-the-skin injection) form of infliximab.
  • You currently have active fistulas (abnormal tunnels) in the area around the back passage.
  • You have a condition called microscopic colitis.

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 20 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: Tom Holvoet, MD, PhD, Department of Gastroenterology, VITAZ Sint-Niklaas

Phone: +32499317005

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
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Registry
ClinicalTrials.gov
Start date
9 April 2024
Est. completion
1 May 2026

Where this trial is recruiting

🇧🇪 Belgium

Primary endpoints

• The proportion of patients that maintain steroid-free clinical and biological remission by week 52 without treatment optimization after switch to SC infliximab (composite endpoint)

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: 20 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