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This trial is complete. It is no longer accepting participants. Results may be available on ClinicalTrials.gov.

NCT01345318

NCT01345318
Completed Phase 2 🇦🇺 Australian site

Who may be able to join

Who might be able to join this trial:

  • 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:

  • 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.

Phase 2: approximately ~30% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.

Trial details

Status
Completed
Phase
Phase 2
Sponsor
Pfizer
Registry
clinicaltrials_gov
Start date
1 June 2011
Est. completion
1 March 2016

Where this trial is recruiting

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

6 site(s) in Australia. Confirm current status and contact details directly with the trial site.

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)

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 30 June 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

View original record on ClinicalTrials.gov