Phase 2 Crohn's Disease and Colitis Trial, Completed NCT01298492 Sponsor: Shire 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 268 people, all of whom received a drug called PF-00547659 at a dose of 75 mg. The trial was a long-term safety study, meaning its main purpose was to track and record any unwanted health events (called adverse events) that participants experienced while taking the drug. By the time the study ended, 149 participants had completed it, while 119 did not finish for various reasons. The reported data shows that out of the 268 people who started, 249 experienced at least one adverse event (an unwanted health occurrence recorded during the study). Of those, 53 had an adverse event serious enough that they stopped taking the drug because of it. Additionally, 80 participants experienced what are classified as "serious adverse events" — meaning events that were life-threatening, required hospitalisation, caused lasting disability, or had other significant consequences. For one of the secondary measures, the reported data shows that 63 participants developed antibodies against the drug itself (meaning their immune system produced a response to the drug). The study also tracked the amount of drug present in participants' blood at various points over time; the reported figures ranged from around 6,670 to roughly 12,960 nanograms per millilitre (nanograms per millilitre is simply a way of measuring how much of a substance is in the blood). 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

NCT01298492
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 must be between 18 and 76 years old.
  • You must have already taken part in one of two specific related studies (called A7281006 or A7281008) and completed the first 12 weeks of treatment, and shown signs that the treatment is working (as defined by those studies).

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 may not be eligible if you finished the 12-week period of the related study but experienced serious side effects linked to the study drug, have an unstable health condition, or if the study doctor feels there is any other reason that would make it unsafe or difficult for you to participate.
  • You may not be eligible if you are currently taking azathioprine, 6-mercaptopurine, or methotrexate (medicines often used to suppress the immune system) at any dose.

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

GP referral letter

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Trial details

Status
Completed
Phase
Phase 2
Sponsor
Shire
Registry
ClinicalTrials.gov
Start date
1 July 2011
Est. completion
27 July 2016

Where this trial was run

🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇯🇵 Japan 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇱 Poland 🇷🇸 Serbia 🇸🇰 Slovakia 🇿🇦 South Africa 🇰🇷 South Korea 🇪🇸 Spain 🇺🇸 United States

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

Number of Participants With On-Treatment Adverse Events (AEs), AEs Led to Withdrawal, and Serious Adverse Events (SAEs)

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