Phase 2 Crohn's Disease and Colitis Trial, Completed NCT01345318 Sponsor: Pfizer 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 (NCT01345318) involved 191 participants who all received the study drug PF-04236921. The trial was measuring two main things: how many participants experienced unwanted medical events (called adverse events) while on treatment, including serious ones or those that led to stopping the treatment; and whether participants' bodies produced certain immune responses (proteins called anti-drug antibodies or neutralising antibodies) that can sometimes develop when a person receives a biological medicine. By the end of the study, 111 participants had completed it, while 80 did not complete it (the reasons for non-completion were not detailed in the reported data). The reported data shows that out of 191 participants who received the drug, 171 experienced at least one adverse event (an unwanted medical occurrence of any kind during treatment), 58 experienced a serious adverse event (meaning a more significant medical event such as hospitalisation or a life-threatening situation), and 54 stopped taking the study drug because of an adverse event. Regarding immune responses, the reported data shows that approximately 0.52% of participants developed anti-drug antibodies, and the same figure of 0.52% was reported for those who developed neutralising antibodies (a specific type that can potentially interfere with how a drug works in the body). It is worth noting that this trial did not include a separate comparison group, so all figures relate solely to participants who received PF-04236921. No data from a placebo or alternative treatment group was reported in the structured results. 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

NCT01345318
Completed Phase 2 🇦🇺 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 a previous related study (called B0151003) and completed the first 12 weeks (84 days) of that study.
  • You must be willing and able to attend scheduled appointments, follow the treatment plan, and complete all required tests and procedures.
  • If you are a woman who could become pregnant and have a male partner who has not had a vasectomy, you must agree to use highly effective birth control from the time you sign the consent form until either 26 weeks after your final study visit, or 62 weeks after your last dose of the study drug if you leave the study early.

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 you finished the first 12 weeks of the previous related study but had a serious side effect linked to the study drug, developed an unstable health condition, or had any other concern that the study doctor believes makes it unsafe for you to continue, you may not be eligible.
  • If you have a serious ongoing or sudden physical or mental health condition, or unusual test results, that could make participation risky or affect the study results, the study doctor may decide you cannot join.
  • If you received any treatments during the previous related study that were not allowed, and the study doctor believes this could affect your safety or the study results, you may not be eligible.

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 24 July 2026

Trial contact details on record

Principal Investigator: Pfizer CT.gov Call Center, Pfizer

Australian sites

Concord Repatriation General Hospital, Concord, New South Wales
Royal Brisbane and Women's Hospital, Brisbane, Queensland
Mater Health Services, South Brisbane, Queensland
Eastern Health, Box Hill Hospital, Box Hill, Victoria
Monash Medical Centre, Clayton, Victoria
St. Vincent's Hospital, Fitzroy, Victoria

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 2
Sponsor
Registry
ClinicalTrials.gov
Start date
1 June 2011
Est. completion
1 March 2016

Where this trial was run

🇦🇺 Australia 🇧🇪 Belgium 🇧🇷 Brazil 🇨🇦 Canada 🇨🇿 Czechia 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇭🇺 Hungary 🇮🇪 Ireland 🇮🇱 Israel 🇮🇹 Italy 🇳🇿 New Zealand 🇨🇭 Switzerland 🇬🇧 United Kingdom 🇺🇸 United States

These are the locations recorded on the registry, including 6 in Australia. 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 Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs), and Discontinuations Due to AEs; Percentage of Participants Developing Anti-Drug Antibodies (ADAs) and Neutralizing Antibodies (NAbs)

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: 24 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