Phase 2 Crohn's Disease and Colitis Trial, Completed NCT00329550 Sponsor: UCB Japan Co. Ltd. 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 40 people with Crohn's disease across three groups. All participants first received a 400 mg dose of the study drug, certolizumab pegol (CZP), during an initial phase. They were then randomly assigned to one of three continuation groups: switching to a placebo (inactive treatment), continuing on a lower 200 mg dose, or continuing on the same 400 mg dose. The trial was measuring disease activity using a scoring system called the Crohn's Disease Activity Index (CDAI) — a number that reflects how severe a person's Crohn's symptoms are, where a score of 150 or below is considered remission (very low disease activity) and above 450 is considered extremely severe. By the end of the study, 5 people in the placebo group, 11 in the 200 mg group, and 12 in the 400 mg group had completed the trial. The reported data shows that at week 26 — the main point the trial was measuring — the percentage of participants whose CDAI score had either dropped by 100 or more points, or reached remission, was 44.4% in the placebo group, 73.3% in the 200 mg continuation group, and 60.0% in the 400 mg continuation group. The trial also tracked how much participants' CDAI scores changed from the start at several points along the way. The reported data shows that across all three groups, average CDAI scores were lower (meaning less severe) than at the start at every time point measured — weeks 8, 12, 16, 20, and 24 — with score reductions generally ranging from around 125 to 163 points depending on the group and the time point. 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 2 Crohn's Disease and Colitis Trial, Completed

NCT00329550
Completed Phase 2

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 took part in a previous related clinical trial (called study C87037 or NCT00291668) and your Crohn's disease symptoms improved during that study.

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 took part in the previous related clinical trial (study C87037 or NCT00291668) but your Crohn's disease got worse during that study and you needed to change your treatment as a result.

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 15 July 2026

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
UCB Japan Co. Ltd.
Registry
ClinicalTrials.gov
Start date
1 May 2006
Est. completion
1 April 2008

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

Percentage of Crohn's Disease Activity Index (CDAI) Responders at Week 26

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: 15 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