Phase 4 Crohn's Disease and Colitis Trial, By Invitation NCT04646187 Sponsor: University Medical Center Groningen Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, By Invitation

NCT04646187
By Invitation Phase 4

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not 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 may be able to join

  • People aged between 12 and 25 years old.
  • People who have been diagnosed with Crohn's disease (the type affecting the digestive tract) or ulcerative colitis.
  • People who are currently receiving infliximab infusions every 8 weeks, or adalimumab injections every 2 weeks.
  • People for whom this is their first anti-TNF medication, or who previously used a different anti-TNF medication that was stopped for a reason other than it not working or stopping to work over time.
  • People who have never had their dosing schedule spaced out or extended before.
  • People who have had three stool (poo) sample tests in a row, taken within the past 6 months, showing inflammation levels within an acceptable range (below 250 μg/g for Crohn's disease, or below 150 μg/g for ulcerative colitis), or who have had a camera examination of the bowel within the past 2 months confirming their condition is in remission (confirm with trial site for exact scoring details).
  • People who are currently not experiencing symptoms of active inflammatory bowel disease, as assessed by their local IBD medical team.
  • People who have provided written consent to participate (for those under 18, the relevant consent requirements should be confirmed with the trial site).

Who may not be able to join

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • People who have a perianal fistula (an abnormal tunnel near the back passage).
  • People who have had a stoma bag (ileostomy) or an internal pouch surgically created from the bowel (ileoanal pouch).
  • People who have another inflammatory condition, such as rheumatoid arthritis.
  • People who are currently taking steroid medications such as prednisone or budesonide.
  • People who are currently pregnant.

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 29 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

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Trial details

Status
By Invitation
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
11 March 2021
Est. completion
1 March 2026

This date has passed while the registry still lists the trial as open to participants. Sponsors often update a trial's status without revising its projected end date, so it may well still be recruiting — but the record is out of date in at least one respect. Check with the study contact before relying on either.

Where this trial is recruiting

🇧🇪 Belgium 🇳🇱 Netherlands 🇪🇸 Spain

Primary endpoints

cumulative incidence of out-of-range fecal calprotectin results at 48 weeks follow-up

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: 29 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