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NCT01465763 · ClinicalTrials.gov registry record · Phase 3
A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 614
- Enrollment target
NCT01465763: Completed Phase 3 study, sponsored by Pfizer.
NCT01465763 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 614 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01465763, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 614 participants
- Enrollment target
Study Summary
This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha therapy.
Primary Outcome
Remission in participants was defined by a total Mayo score of 2 points or lower, with no individual subscore exceeding 1 point and a rectal bleeding subscore of 0. Mayo score is an instrument designed to measure disease activity of ulcerative colitis (UC). It consisted of 4 subscores: stool frequency, rectal bleeding, findings of centrally read flexible proctosigmoidoscopy and physician global assessment (PGA), each graded from 0 to 3 with higher scores indicating more severe disease. These sco
Interventions
- DRUG Placebo
- DRUG tofacitinib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 614 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-05 |
| Phase | Phase 3 |
What the finished NCT01465763 record still lists
NCT01465763 is an interventional study that assigns participants to a tested intervention. The registered 614 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (20% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT01465763 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01465763 about?
NCT01465763 is a clinical study titled "A Study Evaluating The Efficacy And Safety Of CP-690,550 In Patients With Moderate To Severe Ulcerative Colitis". This study is designed to evaluate the efficacy and safety of tofacitinib (CP-690,550) in patients with moderate to severe ulcerative colitis who have failed or be intolerant to one of following treatments for ulcerative colitis: oral steroids, azathiopurine/6-mercaptopurine, or anti-TNF-alpha thera...
What is the current status of trial NCT01465763?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 614 participants. The study started on 2012-04. Estimated completion is 2015-05.
What interventions are being tested in trial NCT01465763?
The interventions under investigation include: Placebo (DRUG), tofacitinib (DRUG).
Who is sponsoring clinical trial NCT01465763?
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 NCT01465763's enrollment target sits among peer trials
614 593rd of 2000 higher than 1,403 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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