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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01442025

NCT01442025
Completed Phase 4

Who may be able to join

Who might be able to join this trial:

  • You are over 18 years old
  • You have active Crohn's disease with visible ulcers seen on a camera test (endoscopy), plus blood or stool test results showing active inflammation
  • You have never previously been treated with biologic medications, and your doctor has recommended starting a type of biologic called anti-TNF therapy based on your country's guidelines
  • You have either never taken thiopurine medications (such as azathioprine) before, or you have tried them but they did not work for you
  • If you are currently taking steroids, your dose has been stable for at least 2 weeks and is not too high (confirm with trial site for exact dose limits)
  • You are willing to receive infliximab infusions on a set schedule and take azathioprine tablets daily as part of the treatment plan

Who may not be able to join:

  • You have no visible ulcers shown on a camera test (endoscopy)
  • You have previously been treated with infliximab specifically (other biologics may be acceptable)
  • You are currently taking high-dose steroids above a certain threshold (confirm with trial site)
  • You previously had to stop taking azathioprine because you could not tolerate it
  • You currently have an active infection
  • Your tuberculosis (TB) screening test came back positive, or you have active or untreated latent TB
  • You have had a serious illness, including most types of cancer, in the last 5 years
  • Your doctor believes you need surgery right away
  • You are currently pregnant or breastfeeding
  • Tests on your stool have found certain harmful bacteria or toxins
  • You are considered unlikely to follow the trial's instructions and schedule
  • You are already taking part in another treatment-based clinical trial

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.

Phase 4: approximately Approved of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 4
Sponsor
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Registry
clinicaltrials_gov
Start date
1 June 2012
Est. completion
1 July 2015

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Level of remission

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: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov