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NCT01458951 · ClinicalTrials.gov registry record · Phase 3
A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Ulcerative Colitis, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 547
- Enrollment target
- 20
- Study locations
NCT01458951: Completed Phase 3 study of Ulcerative Colitis, sponsored by Pfizer.
NCT01458951 is a Phase 3 study of Ulcerative Colitis that has completed, run by Pfizer. The registered enrollment target is 547 participants, below the 2,053-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (73% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458951, a Phase 3 study of Ulcerative Colitis, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 547 participants
- Enrollment target
- 20
- Study locations
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 . 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 scores
Conditions Studied
Interventions
- DRUG Placebo
- DRUG tofacitinib
Study Locations (20)
California
- Alliance Clinical Research - Oceanside
- Clinical Application Laboratories - San Diego
- San Diego Endoscopy Center - San Diego
- UCSF Endoscopy Unit at Mount Zion - San Francisco
- University of California San Francisco - San Francisco
- Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center - Torrance
Florida
- Citrus Surgery & Endoscopy Center (Colonoscopy) - Crystal River
- Nature Coast Clinical Research - Inverness
- Suncoast Endoscopy Center (colonoscopy) - Inverness
- Gastroenterology Group of Naples - Naples
- Advanced Gastroenterology Center - Port Orange
- Advanced Medical Research Center - Port Orange
Connecticut
- Bristol Hospital - Bristol
- Connecticut Clinical Research Foundation - Bristol
- Yale New Haven Hospital - New Haven
- Yale University School of Medicine - New Haven
- Central Connecticut Endoscopy Center - Plainville
Arizona
- Desert Sun Clinical Research, LLC - Tucson
- Desert Sun Gastroenterology - Tucson
- Desert Sun Surgery Center - Tucson
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 547 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-06 |
| Phase | Phase 3 |
What the finished NCT01458951 record still lists
NCT01458951 is an interventional study that assigns participants to a tested intervention. The registered 547 participants enrollment target is mid-sized for trials with a published cap, below the 2,053-participant average among 122 other Ulcerative Colitis trials with a reported enrollment target (73% lower).
The record links to 1 condition, with Ulcerative Colitis appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT01458951 names 20 study sites across 4 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT01458951 about?
NCT01458951 is a clinical study titled "A Study To Evaluate Both The Efficacy and Safety Profile of CP-690,550 In Patients With Moderately to Severely Active 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 NCT01458951?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 547 participants. The study started on 2012-06. Estimated completion is 2015-06.
What conditions does trial NCT01458951 study?
This clinical trial studies the following conditions: Ulcerative Colitis.
What interventions are being tested in trial NCT01458951?
The interventions under investigation include: Placebo (DRUG), tofacitinib (DRUG).
Who is sponsoring clinical trial NCT01458951?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01458951 being conducted?
This trial has 20 study locations across Arizona, California, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Ulcerative Colitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01458951's enrollment target sits among peer trials
547 19th of 122 higher than 104 of 122 other Ulcerative Colitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ulcerative Colitis 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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