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

NCT01393626

NCT01393626
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You are between 18 and 75 years old (note: the upper age limit is 64 in India and 65 in the Netherlands)
  • You have been diagnosed with Crohn's disease for at least 6 months before the screening visit
  • Your Crohn's disease is currently moderately to severely active, affecting the small intestine, large intestine, or both, as measured by a standard scoring system called the CDAI (confirm with trial site)

Who may not be able to join:

  • You have been diagnosed with a different type of bowel disease, such as ulcerative colitis or indeterminate colitis, or have symptoms that suggest you may have ulcerative colitis
  • You have Crohn's disease but have never received any treatment for it before
  • You have taken certain immune-suppressing medications called azathioprine, 6-mercaptopurine, or methotrexate within the past 2 weeks
  • You have received a type of treatment called anti-TNFα therapy (a specific kind of medication that targets inflammation) within the past 8 weeks
  • You have received interferon therapy within the past 8 weeks
  • You have taken certain other immune-suppressing medicines (cyclosporine, mycophenolate, or tacrolimus) within the past 4 weeks
  • You have received corticosteroids given directly into a vein (by IV) within the past 2 weeks

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 2: approximately ~30% 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 2
Sponsor
Pfizer
Registry
clinicaltrials_gov
Start date
1 October 2011
Est. completion
1 February 2015

Where this trial is recruiting

🇦🇺 Australia 🇦🇹 Austria 🇧🇬 Bulgaria 🇨🇦 Canada 🇭🇷 Croatia 🇨🇿 Czechia 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇭🇺 Hungary 🇮🇱 Israel 🇯🇵 Japan 🇳🇱 Netherlands 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇺🇦 Ukraine 🇺🇸 United States

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

Primary endpoints

Percentage of Participants in Clinical Remission (as Defined by a Crohn's Disease Activity Index [CDAI] Score of Less Than [<] 150 Points) at Week 8

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