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NCT01190839

NCT01190839
Terminated Phase 3 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been officially diagnosed with Crohn's disease, confirmed through camera examinations of the gut, tissue samples, and/or imaging scans before or during surgery
  • You have had surgery to remove part of your small intestine and colon (ileocolonic resection)
  • You are considered to be at a higher-than-average risk of your Crohn's disease coming back after surgery
  • You have either never taken infliximab (a medication used to treat Crohn's disease) or have taken it before but did not have to stop due to side effects — previous use of similar medications (adalimumab or certolizumab) is allowed
  • You have been tested for hepatitis B virus (HBV) before starting the trial
  • Your Crohn's disease activity score (a measure of how active your symptoms are) is below 200, meaning your disease is currently not in an active flare
  • Your blood and liver test results are within an acceptable range

Who may not be able to join:

  • You have a history of certain serious fungal or bacterial infections, including histoplasmosis or coccidioidomycosis, before the screening period
  • Your chest X-ray (taken within the last 3 months) shows any concerning findings, such as signs of cancer, infection, or tuberculosis (TB)
  • You still had active Crohn's disease areas in your gut that were not removed during your surgery
  • You do not meet the specific criteria for being at increased risk of Crohn's disease returning after surgery
  • You currently have an active infection, or you have had a serious infection unrelated to Crohn's disease (such as hepatitis, pneumonia, or a kidney infection) within the past 6 months
  • You have had a serious opportunistic infection (such as shingles, cytomegalovirus, or certain fungal or bacterial infections) within the past 6 months
  • You have, or have had, any form of cancer within the past 5 years — with the exception of certain minor skin cancers that were fully removed and have not come back
  • You have any other health condition that the trial doctor believes could put your wellbeing at risk or prevent you from fully participating in the 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 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.

Trial details

Status
Terminated
Phase
Phase 3
Sponsor
Janssen Biotech, Inc.
Registry
clinicaltrials_gov
Start date
1 November 2010
Est. completion
1 December 2014

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇳🇱 Netherlands 🇳🇿 New Zealand 🇵🇱 Poland 🇬🇧 United Kingdom 🇺🇸 United States

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Percentage of Participants With Clinical Recurrence (CR) of Crohn's Disease (CD) Prior to or at Week 76

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