Phase 3 Crohn's Disease and Colitis Trial, Completed NCT00805766 Sponsor: Tanabe Pharma Corporation Condition: Crohn's Disease and Colitis
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 45 people with Crohn's disease — a condition that causes inflammation in the digestive tract. All participants received a treatment called TA-650 (a type of medication given by infusion). The trial had two stages: a screening period and an "increased dose period." Of the 45 who started the screening stage, 39 moved into the increased dose stage, and 26 completed that second stage. The trial was primarily measuring changes in a scoring system called the Crohn's Disease Activity Index (CDAI), which is a tool that rates disease symptoms on a scale roughly from 0 to 600 — where lower scores indicate fewer symptoms, and a score below 150 is considered "clinical remission" (meaning very low disease activity). The reported data shows that the main thing being tracked — the median change in CDAI score from the start to week 8 of the increased dose period — was a decrease of 95 points (in this trial, a decrease in symptoms was recorded as a positive number). The trial was aiming to confirm a decrease of at least 50 points, so the reported figure exceeded that target. The reported data also shows CDAI scores measured at various points during the increased dose period, ranging from around 105 to 297, and the proportion of participants whose scores fell into the "clinical remission" range (below 150) varied across time points, with figures reported between approximately 28% and 70% at different check-ins. The blood levels of TA-650 were also measured at multiple time points and fluctuated considerably across the study period. Additionally, the reported data shows that antibodies to TA-650 — proteins the body can sometimes produce in response to a treatment — were detected in approximately 23% of participants during the screening period and around 18% during the increased dose period, with the majority of participants (around 72–77%) showing no detectable antibodies at those time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Crohn's Disease and Colitis Trial, Completed

NCT00805766
Completed Phase 3

voxsanity.com.au · Eligibility summary from public government registries · 18 August 2026 · not medical advice

Who may and may not be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who may be able to join

  • 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

Each point below is a reason the trial team may not be able to accept someone. It is not a list of requirements to meet.

  • 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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 31 July 2026

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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 was run

🇯🇵 Japan

These are the locations recorded on the registry, and they are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

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

Other options

Expanded access pathways

This trial is not enrolling. Other access pathways exist in general: in Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients. Whether it applies to any treatment studied here is a question for your doctor — nothing on this page says it does.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 31 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov