Phase 4 Crohn's Disease and Colitis Trial, Recruiting NCT06180382 Sponsor: Centre Hospitalier Universitaire de Saint Etienne Condition: Crohn's Disease and Colitis
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Phase 4 Crohn's Disease and Colitis Trial, Recruiting

NCT06180382
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:

  • Adults (18 and over) who have given their consent to take part in the study
  • People who have Crohn's disease and initially responded well to Adalimumab (a standard dose of 40 mg every two weeks), but have since stopped responding to it as well as before
  • People who are covered by a social security or health insurance scheme

Who may not be able to join:

  • People who are pregnant
  • People who are unable to have an MRI scan, a small camera capsule test (VCE), a bowel camera examination (ileocolonoscopy), or an ultrasound within one month before joining the study
  • People who have previously used or are currently using vedolizumab or ustekinumab for Crohn's disease, or who have taken part in a clinical trial involving a biological medicine
  • People currently taking immunomodulator medicines (a type of medication that affects the immune system) at the same time
  • People currently taking corticosteroids (steroid medicines)
  • People with a history of cancer
  • People with a history of HIV, immune system disorders, diseases affecting the nervous system such as demyelinating conditions, nerve-related symptoms that may suggest such conditions, frequent recurring infections, active tuberculosis (whether treated or untreated), or serious infections such as blood poisoning or opportunistic infections
  • People who have a pouch or a surgically reconnected bowel following removal of part of the intestine (confirm with trial site)
  • People who have short bowel syndrome, as determined by the trial investigator
  • People who are receiving nutrition directly into their bloodstream (total parenteral nutrition)
  • People who are receiving nutrition through a feeding tube (enteral nutrition)
  • People who are under legal guardianship or who are otherwise unable to give their own consent
  • People who have a different type of inflammatory bowel disease, specifically haemorrhagic rectocolitis or indeterminate colitis
  • People currently taking other immunosuppressive medicines at the same time
  • People who are already on an increased or optimised dose of Adalimumab
  • People who never responded to Adalimumab in the first place
  • People who were treated with infliximab or ustekinumab before starting Adalimumab
  • People experiencing a very severe flare of Crohn's disease, measured by a CDAI score above 330 (a clinical score used to assess disease severity — confirm with trial site)
  • People whose Crohn's disease affects the area around the anus
  • People with Crohn's disease who have a temporary or permanent stoma (a surgically created opening on the abdomen for waste to leave the body)

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 26 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: Mathilde BARRAU, MD, CHU de Saint-Etienne

Phone: (0)477829626

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
Centre Hospitalier Universitaire de Saint Etienne
Registry
ClinicalTrials.gov
Start date
31 October 2024
Est. completion
31 October 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

ADA optimized versus Vedolizumab as second line

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: 26 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