Phase 4 Crohn's Disease and Colitis Trial, Recruiting
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.
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
Where this trial is recruiting
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?
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.