Phase 2 Crohn's Disease and Colitis Trial, Completed NCT01287897 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 (NCT01287897) enrolled 250 adults with Crohn's disease across four groups: 70 received a placebo (dummy treatment), 69 received a 10 mg dose of the experimental drug PF-04236921, 71 received a 50 mg dose, and 40 received a 200 mg dose. The trial was measuring whether participants' Crohn's disease symptoms improved, using a scoring tool called the Crohn's Disease Activity Index (CDAI) — a questionnaire-based score that tracks symptoms over a week. The main thing being measured was whether a participant's CDAI score dropped by 70 points or more from their starting score (called a "CDAI-70 response"), checked at 8 weeks and again at 12 weeks. The reported data shows the following percentages of participants whose scores dropped by at least 70 points. At 8 weeks: 30.6% of the placebo group, 35.0% of the 10 mg group, and 49.3% of the 50 mg group showed this level of score reduction. In the separate comparison involving the 200 mg group, 28.8% of the placebo participants and 39.0% of the 200 mg participants showed this reduction at 8 weeks. At 12 weeks, the reported figures were 28.6% (placebo), 35.2% (10 mg), and 47.4% (50 mg); and in the 200 mg comparison, 26.7% (placebo) versus 41.7% (200 mg). The secondary outcomes tracked these same response rates at earlier time points across the weeks of the study, and the reported data shows the percentages in each group changing gradually over time in a similar pattern. 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

NCT01287897
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

Here is the eligibility information in plain English:

Who may be able to join

  • You have tried anti-TNF medications (a type of treatment for inflammatory conditions) but they did not work for you, or you were unable to tolerate them
  • Your blood test shows a certain level of inflammation in your body (a marker called hsCRP of 5.0 mg/L or higher)
  • A camera examination of your bowel (colonoscopy) done within 8 weeks before joining the study has shown open sores (ulcers) in your digestive tract, scored using a specific rating system called SES-CD

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.

  • Women who are pregnant or currently breastfeeding
  • People with Crohn's Disease who have active tunnels or pockets of infection forming between body tissues (fistulae or abscesses)
  • People who have had inflammation of small pouches in the bowel wall (diverticulitis), or who have uncomfortable symptoms related to those pouches
  • People whose blood tests at the start of the study show abnormal results in blood counts or other chemical measurements (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 8 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
Nepean Public Hospital, Kingswood, New South Wales
Royal Brisbane and Women's Hospital, Herston, Brisbane, Queensland
Mater Health Services, South Brisbane, Queensland
Eastern Health, Box Hill Hospital, Box Hill, Victoria
Monash Medical Centre, Clayton, Victoria
The Royal Melbourne Hospital, Parkville, Victoria
St. Vincent's Hospital Melbourne, Fitzroy,

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 February 2011
Est. completion
1 September 2014

Where this trial was run

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

These are the locations recorded on the registry, including 8 in Australia. They are a historical record: this trial is not enrolling, so they are not places you can join it.

Primary endpoints

The Crohn's Disease Activity Index (CDAI)-70 Response Rate at Week 8 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; The CDAI-70 Response Rate at Week 8 in Participants Who Received Placebo and PF-04236921 200 mg; The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo, PF-04236921 10 mg and PF-04236921 50 mg; The CDAI-70 Response Rate at Week 12 in Participants Who Received Placebo and PF-04236921 200 mg

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: 8 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