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NCT01345318 · ClinicalTrials.gov registry record · Phase 2
B0151005 Open-Label Extension Study
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 191
- Enrollment target
NCT01345318: Completed Phase 2 study, sponsored by Pfizer.
NCT01345318 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 191 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (44% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01345318, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 191 participants
- Enrollment target
Study Summary
This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non responders.
Primary Outcome
An AE was any untoward medical occurrence without regard to causality in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of death); persistent or significant disability/incapacity; congenital anomaly. Lack of efficacy was reported as an AE when it was associated with a SAE. An AE was considered treatment
Interventions
- BIOLOGICAL PF-04236921
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 191 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-03 |
| Phase | Phase 2 |
What the finished NCT01345318 record still lists
NCT01345318 is an interventional study that assigns participants to a tested intervention. The registered 191 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 (44% higher).
The record links to 0 conditions, and to 1 intervention - of which PF-04236921 is the first listed.
NCT01345318 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01345318 about?
NCT01345318 is a clinical study titled "B0151005 Open-Label Extension Study". This is a multi-center Phase 2, open label, safety extension study in subjects with moderate to severe CD who are anti-TNF inadequate responders. Subjects eligible for this study will have completed the 12-week induction period of study B0151003 and will be enrolled as either responders or non respo...
What is the current status of trial NCT01345318?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 191 participants. The study started on 2011-06. Estimated completion is 2016-03.
What interventions are being tested in trial NCT01345318?
The interventions under investigation include: PF-04236921 (BIOLOGICAL).
Who is sponsoring clinical trial NCT01345318?
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 NCT01345318's enrollment target sits among peer trials
191 353rd of 2000 higher than 1,648 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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