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

NCT00771667

NCT00771667
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Crohn's disease (including a type involving abnormal tunnels called fistulas) for at least 3 months.
  • You have previously been treated with at least one of these medications at the standard approved dose: Remicade (infliximab), Humira (adalimumab), or Cimzia (certolizumab pegol).
  • Your Crohn's disease did not respond well to, or you could not tolerate, Remicade, Humira, or Cimzia.
  • You are 18 years of age or older.
  • Your Crohn's disease is currently active, based on a scoring system called the Crohn's Disease Activity Index (confirm with trial site for exact score details).

Who may not be able to join:

  • You have had bowel surgery, a rerouting of your digestive system, or a stoma (an opening created in the abdomen) within the last 6 months.
  • You are currently pregnant, breastfeeding, or planning to become pregnant (this applies to both men and women) during the study or within 1 year after receiving the study treatment.
  • You received Remicade, Humira, or Cimzia within 8 weeks before the start of the study treatment.
  • You have certain serious complications related to your Crohn's disease that would make it difficult to measure how well the study drug is working (confirm with trial site for specifics).
  • You have a history of, or currently have, a long-lasting or frequently returning infectious disease.

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
Centocor, Inc.
Registry
clinicaltrials_gov
Start date
1 December 2008
Est. completion
1 May 2010

Where this trial is recruiting

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

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

Primary endpoints

Number of Participants With Clinical Response at Week 6

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