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NCT01287897 · ClinicalTrials.gov registry record · Phase 2
A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 250
- Enrollment target
NCT01287897: Completed Phase 2 study, sponsored by Pfizer.
NCT01287897 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 250 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01287897, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 250 participants
- Enrollment target
Study Summary
This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's Disease.
Primary Outcome
CDAI-70 response was defined as a decrease in CDAI score of 70 or greater from baseline. The proportions of participants with CDAI-70 response at Week 8 were compared between placebo and PF-04236921 10 mg/50 mg. CDAI is used to quantify the symptoms of patients with Crohn's Disease. CDAI evaluates 8 Crohn's disease-related variables during a 1-week assessment period, yielding a composite score greater than or equal to (\>=) 0 and without an upper limit. Many clinical trials use the endpoint for
Interventions
- DRUG PF-04236921 SC injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 250 participants |
| Start Date | 2011-02 |
| Est. Completion | 2015-02 |
| Phase | Phase 2 |
What the finished NCT01287897 record still lists
NCT01287897 is an interventional study that assigns participants to a tested intervention. The registered 250 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (88% higher).
The record links to 0 conditions, and to 1 intervention - of which PF-04236921 SC injection is the first listed.
NCT01287897 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01287897 about?
NCT01287897 is a clinical study titled "A Study To Assess The Efficacy And Safety Of PF-04236921 In Subjects With Crohn's Disease Who Failed Anti-TNF Therapy". This is a proof of concept study to determine the efficacy and safety of a monoclonal antibody with three doses versus placebo. Subjects will be randomized to a treatment and the dose will be delivered subcutaneously twice, 4 weeks apart. All subjects will have moderate to severe refractory Crohn's ...
What is the current status of trial NCT01287897?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 250 participants. The study started on 2011-02. Estimated completion is 2015-02.
What interventions are being tested in trial NCT01287897?
The interventions under investigation include: PF-04236921 SC injection (DRUG).
Who is sponsoring clinical trial NCT01287897?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01287897's enrollment target sits among peer trials
250 222nd of 2000 higher than 1,768 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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