Phase 3 Crohn's Disease and Colitis Trial, Recruiting NCT05040464 Sponsor: Centre Hospitalier Universitaire, Amiens Condition: Crohn's Disease and Colitis
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Phase 3 Crohn's Disease and Colitis Trial, Recruiting

NCT05040464
Recruiting Phase 3

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 are male or female and over 18 years old
  • You have been diagnosed with Crohn's disease for at least 6 weeks
  • Your Crohn's disease is currently active, based on a standard symptom scoring system (confirm with trial site)
  • Tests (a camera examination of your gut) show active inflammation in your digestive tract at the start of the trial
  • Your Crohn's disease has not responded well to standard treatments, or you cannot take them due to side effects or medical reasons, and you are about to start treatment with a medicine called adalimumab
  • You are being cared for at a medical centre that is part of a specific French research network called GETAID
  • If you are able to have children, you agree to use reliable contraception during the trial
  • You are willing and able to give written consent to take part

Who may not be able to join:

  • You have a short bowel, a stoma (bowel opening on your abdomen), a significant bowel narrowing causing symptoms, an abscess, or have had abdominal surgery within the last 3 months
  • You have a bowel narrowing that cannot be passed by a camera during examination
  • You have previously had a bad reaction or intolerance to certain medicines used for Crohn's disease (thiopurines or methotrexate)
  • You have previously been treated with adalimumab
  • You have a medical reason why you cannot take immune-suppressing medicines or anti-TNF treatments (confirm with trial site)
  • You have another serious illness that could affect your ability to take part in the trial
  • You are pregnant, breastfeeding, planning to become pregnant, or not using contraception
  • You have a known problem with substance misuse
  • You have taken part in another clinical trial and used an experimental medicine within the last 30 days
  • You are an adult who is legally protected or under guardianship (confirm with trial site)

⚠️ 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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 03 22 08 88 51

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 3
Sponsor
Centre Hospitalier Universitaire, Amiens
Registry
ClinicalTrials.gov
Start date
26 August 2021
Est. completion
1 August 2026

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Variation of the endoscopic response between AZA and MTX groups

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