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

NCT00805766

NCT00805766
Completed Phase 3

Who may be able to join

Who might be able to join this trial:

  • You have been diagnosed with Crohn's disease
  • Your Crohn's disease symptoms have come back within the last 8 weeks, even though you have been taking a regular maintenance dose of REMICADE (infliximab), and your doctor feels the current treatment is not working well enough for you

Who may not be able to join:

  • You have a severe narrowing in your intestine, have been diagnosed with short bowel syndrome, or have previously had surgery to create a stoma (an opening in the abdomen to redirect the bowel)
  • You have a significant internal fistula (an abnormal tunnel between organs inside the body) that may require surgery (confirm with trial site)
  • You have previously had a serious reaction during a REMICADE infusion
  • You are pregnant, breastfeeding, or think you may be pregnant
  • You have taken part in another clinical trial and received an experimental treatment within the last 12 weeks before giving consent
  • Your doctor does not feel it would be appropriate for you to take part in this study for any reason

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
Completed
Phase
Phase 3
Sponsor
Tanabe Pharma Corporation
Registry
clinicaltrials_gov
Start date
1 December 2008
Est. completion
1 November 2009

Where this trial is recruiting

🇯🇵 Japan

Primary endpoints

Median Crohn's Disease Activity Index (CDAI) Change From Week 0 to Week 8 in the Increased Dose Period

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