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NCT01276509 · ClinicalTrials.gov registry record · Phase 2
Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease
A Phase 2 study, sponsored by Shire.
- Completed
- Registry status
- Phase 2
- Development phase
- 265
- Enrollment target
NCT01276509: Completed Phase 2 study, sponsored by Shire.
NCT01276509 is a Phase 2 study that has completed, run by Shire. The registered enrollment target is 265 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (99% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01276509, a Phase 2 study, has completed, sponsored by Shire.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 265 participants
- Enrollment target
Study Summary
Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
Primary Outcome
Crohn's Disease Activity Index (CDAI) is a number which consists of information collected from a 7-day diary from the participants regarding symptoms. Remission is considered a score of 150 or less. Active disease is considered 200 or greater. A response to therapy is considered a decline in CDAI score of 70-points from baseline. CDAI response rate at week 8 and week 12 was measured between the investigational product group and the placebo group.
Interventions
- DRUG PF-00547659 SC injection
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 265 participants |
| Start Date | 2011-04-06 |
| Est. Completion | 2015-10-09 |
| Phase | Phase 2 |
What the finished NCT01276509 record still lists
NCT01276509 is an interventional study that assigns participants to a tested intervention. The registered 265 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 (99% higher).
The record links to 0 conditions, and to 1 intervention - of which PF-00547659 SC injection is the first listed.
NCT01276509 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01276509 about?
NCT01276509 is a clinical study titled "Study To Test Whether PF-00547659 Is Safe And Improves Disease Symptoms In Patients With Crohn's Disease". Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.
What is the current status of trial NCT01276509?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 265 participants. The study started on 2011-04-06. Estimated completion is 2015-10-09.
What interventions are being tested in trial NCT01276509?
The interventions under investigation include: PF-00547659 SC injection (DRUG).
Who is sponsoring clinical trial NCT01276509?
This trial is sponsored by Shire, which has 245 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01276509's enrollment target sits among peer trials
265 210th of 2000 higher than 1,791 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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