Phase 3 Crohn's Disease and Colitis Trial, Completed NCT00552058 Sponsor: UCB Pharma 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 439 people with Crohn's disease — a chronic inflammatory bowel condition. Of these, 223 received a medicine called certolizumab pegol and 216 received a placebo (a dummy treatment with no active ingredient). The trial was measuring whether certolizumab pegol could bring Crohn's disease symptoms down to a low level (called "clinical remission") by week 6, as judged by a standard symptom scoring tool called the Crohn's Disease Activity Index (CDAI), where a score of 150 or below counts as remission. Most participants completed the study — 207 in the medicine group and 192 in the placebo group. The reported data shows that at week 6, 31.6% of people in the certolizumab pegol group had reached clinical remission, compared with 25.4% in the placebo group. For the secondary measures, 40.5% of the medicine group showed a meaningful reduction in their symptom score (at least a 100-point drop) versus 34.0% in the placebo group. On a quality-of-life questionnaire specific to bowel disease, 36.7% of the medicine group reached the remission threshold compared with 28.7% in the placebo group. The reported data also shows that the average CDAI symptom score fell by 96.7 points in the medicine group and 73.1 points in the placebo group from the start of the trial to week 6. At the earlier two-week check, 23.3% of the medicine group and 15.8% of the placebo group had reached remission. 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

NCT00552058
Completed Phase 3 🇦🇺 Australian site

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 can be either male or female
  • You must be between 18 and 75 years old (inclusive)
  • You have been officially diagnosed with Crohn's disease
  • Your Crohn's disease is currently considered moderate to severe, based on a specific scoring system called the CDAI (with a score between 225 and 450)
  • You have never previously been treated with a type of medication called anti-TNF drugs (examples include infliximab or adalimumab — confirm with trial site if unsure whether your medication counts)

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 previously taken part in a clinical study involving a drug called certolizumab pegol
  • You do not meet certain general health requirements that are standard for this type of Crohn's disease research (confirm with trial site for the full details of these requirements)

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 29 July 2026

Trial contact details on record

Principal Investigator: UCB Clinical Trial Call Center, +1 877 822 9493 (UCB)

Australian sites

, Concord, New South Wales
, Box Hill, Victoria
, Footscray, Victoria
, Parkville, Victoria
, Adelaide,
, Bankstown,
, Clayton,
, Fitzroy,
, Fremantle,
, Garran,

This trial is not accepting new participants. These are the contact details ClinicalTrials.gov holds for it, kept here for reference. They are not an invitation to enrol, and the sites listed may no longer be running this trial.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Completed
Phase
Phase 3
Sponsor
UCB Pharma
Registry
ClinicalTrials.gov
Start date
1 March 2008
Est. completion
1 October 2009

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇱 Chile 🇨🇿 Czechia 🇪🇪 Estonia 🇫🇮 Finland 🇩🇪 Germany 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇳🇿 New Zealand 🇵🇱 Poland 🇷🇴 Romania 🇷🇺 Russia 🇺🇦 Ukraine 🇺🇸 United States

These are the locations recorded on the registry, including 10 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

Percentage of Subjects in Clinical Remission at Week 6

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: 29 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