Phase 2 Crohn's Disease and Colitis Trial, Completed NCT00771667 Sponsor: Centocor, Inc. 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 looked at ustekinumab as a treatment for Crohn's disease — a condition causing ongoing inflammation in the digestive tract. The trial ran in two phases. In the first phase (the "induction phase"), 526 people took part and were split into four groups: one group received a dummy treatment (placebo), and the other three groups received different doses of ustekinumab given by intravenous drip (directly into the vein). The trial used a scoring tool called the Crohn's Disease Activity Index (CDAI), which runs from 0 (very little disease activity) to over 600 (very severe), to measure whether participants' symptoms improved. The main thing the trial was measuring was how many people showed a meaningful drop in their CDAI score — called a "clinical response" — by week 6. The reported data shows that at week 6, out of 132 people in the placebo group, 31 met the criteria for clinical response. In the three ustekinumab dose groups (131, 132, and 131 people respectively), the numbers were 48, 45, and 52. For "clinical remission" — meaning symptoms dropped to a very low level (a CDAI score below 150) — at week 6, the reported figures were 14 in the placebo group and 21, 21, and 16 across the three ustekinumab groups. At week 8, clinical response numbers were 23 (placebo), 42, 42, and 57 (ustekinumab groups), and remission numbers were 14, 23, 24, and 24 respectively. People who responded by week 6 then moved into a second "maintenance phase," where some continued on ustekinumab injections under the skin and others received placebo injections. Among those responders, at week 22, the reported data shows 20 out of those on placebo injections were in remission, compared with 30 out of those receiving ustekinumab injections under the skin. 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

NCT00771667
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 have been diagnosed with Crohn's disease (including a type involving abnormal tunnels called fistulas) for at least 3 months.
  • You have previously been treated with at least one of these medications at the standard approved dose: Remicade (infliximab), Humira (adalimumab), or Cimzia (certolizumab pegol).
  • Your Crohn's disease did not respond well to, or you could not tolerate, Remicade, Humira, or Cimzia.
  • You are 18 years of age or older.
  • Your Crohn's disease is currently active, based on a scoring system called the Crohn's Disease Activity Index (confirm with trial site for exact score details).

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 had bowel surgery, a rerouting of your digestive system, or a stoma (an opening created in the abdomen) within the last 6 months.
  • You are currently pregnant, breastfeeding, or planning to become pregnant (this applies to both men and women) during the study or within 1 year after receiving the study treatment.
  • You received Remicade, Humira, or Cimzia within 8 weeks before the start of the study treatment.
  • You have certain serious complications related to your Crohn's disease that would make it difficult to measure how well the study drug is working (confirm with trial site for specifics).
  • You have a history of, or currently have, a long-lasting or frequently returning infectious disease.

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 28 July 2026

Trial contact details on record

Principal Investigator: Centocor, Inc. Clinical Trial, Centocor, Inc.

Australian sites

, Adelaide,
, Bankstown,
, Bedford Park,
, Box Hill,
, Concord,
, East Melbourne,
, Fitzroy,
, Frankston,
, Fremantle,
, Garran,
, Herston,
, Parkville,
, Prahran,
, South Brisbane,

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
Centocor, Inc.
Registry
ClinicalTrials.gov
Start date
1 December 2008
Est. completion
1 May 2010

Where this trial was run

🇦🇺 Australia 🇦🇹 Austria 🇧🇪 Belgium 🇨🇦 Canada 🇫🇷 France 🇩🇪 Germany 🇮🇱 Israel 🇳🇱 Netherlands 🇳🇿 New Zealand 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 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

Number of Participants With Clinical Response 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: 28 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