Phase 3 Crohn's Disease and Colitis Trial, Completed NCT00160524 Sponsor: UCB Pharma SA 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 (NCT00160524) enrolled 595 participants, all of whom received the study drug certolizumab pegol. The trial ran for up to 84 months (seven years) and was an open-label extension study, meaning it followed on from two earlier trials. Of the 595 people who started, 117 completed the study and 478 did not complete it for various reasons. The study was primarily measuring how many participants experienced unwanted medical events (called adverse events) over the course of the trial. It also tracked things like participants' bowel disease symptoms using a scoring tool called the Harvey Bradshaw Index (HBI), which rates factors like general wellbeing, abdominal pain, and the number of loose stools per day — with lower scores indicating better wellbeing. The reported data shows that 88.2% of participants experienced at least one adverse event (any untoward medical occurrence) during the study, and 40.3% experienced at least one serious adverse event — defined as events such as death, a life-threatening situation, hospitalisation, or significant lasting disability. Regarding the secondary outcomes, 54.7% of participants had an HBI score of 4 or below (indicating remission, or low symptom burden on that scale) at their final visit, while 21.7% showed a response, meaning their HBI score dropped by 3 or more points from the start of the earlier feeder studies. The reported data also shows that 22.6% of participants developed antibodies to certolizumab pegol at some point during the combined study period, and the average measured level of the drug in participants' blood at their final visit was 5.578 micrograms per millilitre (a measure of how much of the drug was present in the bloodstream). 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

NCT00160524
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 must have already taken part in one of two specific earlier studies (called CDP870-031 or CDP870-032) and completed it at the 26-week point, whether you received the active treatment, a dummy treatment (placebo), or both.
  • You must be able to understand the information given to you about the trial and sign a written consent form agreeing to take part.

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.

  • If there was any reason you would not have been allowed to join the earlier qualifying study (CDP870-031 or CDP870-032), that same reason may stop you from joining this trial — please check with the trial site for details on what those reasons were.
  • Note: having previously taken part in a clinical trial of the medicine called Certolizumab Pegol does not automatically exclude you from this trial (confirm with trial site).
  • There is no restriction based on how active or severe your condition is at the time of joining this trial (confirm with trial site).

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

Trial contact details on record

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

Australian sites

11001, Adelaide,
11016, Ballarat,
11011, Bankstown,
11007, Box Hill,
11013, Frankston,
11010, Fremantle,
11015, Garran,
11017, Herston,
11014, Lauceston,
11003, Melbourne,
11004, Melbourne,
11005, New Lambton,
11018, Newtown,
11012, Parkville,

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 SA
Registry
ClinicalTrials.gov
Start date
1 July 2004
Est. completion
1 August 2012

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria Belarus 🇧🇪 Belgium 🇧🇬 Bulgaria 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇪🇪 Estonia 🇬🇪 Georgia 🇩🇪 Germany Hong Kong 🇭🇺 Hungary 🇮🇱 Israel 🇮🇹 Italy 🇱🇻 Latvia 🇱🇹 Lithuania 🇳🇿 New Zealand 🇳🇴 Norway 🇵🇱 Poland 🇷🇺 Russia 🇷🇸 Serbia 🇸🇬 Singapore 🇸🇮 Slovenia 🇿🇦 South Africa 🇪🇸 Spain 🇸🇪 Sweden 🇺🇦 Ukraine 🇺🇸 United States

These are the locations recorded on the registry, including 14 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 With at Least One Adverse Event (AE) During the Duration of the Study CDP870-033 (up to 84 Months); Percentage of Subjects With at Least One Serious Adverse Event (SAE) During the Duration of This Study CDP870-033 (up to 84 Months)

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