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NCT01458574 · ClinicalTrials.gov registry record · Phase 3
A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 593
- Enrollment target
NCT01458574: Completed Phase 3 study, sponsored by Pfizer.
NCT01458574 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 593 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (23% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01458574, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 593 participants
- Enrollment target
Study Summary
The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and improves quality of life in subjects with UC.The study proposes to assess CP-690,550 pharmacokinetic exposure during maintenance therapy in subjects over the age of 18 years with UC.
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 was 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 sigmoidoscopy and physician global assessment (PGA), each subscore graded from 0 to 3 with higher scores indicating higher disease severity. T
Interventions
- DRUG Placebo
- DRUG CP-690,550
- DRUG CP690,550
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 593 participants |
| Start Date | 2012-07-20 |
| Est. Completion | 2016-05-27 |
| Phase | Phase 3 |
What the finished NCT01458574 record still lists
NCT01458574 is an interventional study that assigns participants to a tested intervention. The registered 593 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 (23% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT01458574 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01458574 about?
NCT01458574 is a clinical study titled "A Study Of Oral CP-690,550 As A Maintenance Therapy For Ulcerative Colitis". The study proposes to assess whether compared to placebo, CP-690,550 is effective, safe, and tolerable maintenance therapy in subjects with Ulcerative Colitis (UC). The study proposes to assess whether compared to placebo, CP-690,550 maintenance therapy more effectively achieves mucosal healing and ...
What is the current status of trial NCT01458574?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 593 participants. The study started on 2012-07-20. Estimated completion is 2016-05-27.
What interventions are being tested in trial NCT01458574?
The interventions under investigation include: Placebo (DRUG), CP-690,550 (DRUG), CP690,550 (DRUG).
Who is sponsoring clinical trial NCT01458574?
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 NCT01458574's enrollment target sits among peer trials
593 643rd of 2000 higher than 1,358 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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