CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 593 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Placebo 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01458574
NCT01458574Phase 3Completed
CompareCT.gov

A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As A Maintenance Therapy In Subjects With Ulcerative Colitis

Pfizer·interventional·Posted Oct 25, 2011·Updated May 18, 2017

In Brief

A Phase 3 clinical trial evaluating Placebo, CP690,550, and 1 other intervention for Ulcerative Colitis. Completed, enrolled 593 participants across 275 sites in 31 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Austria, Belgium, Brazil, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, South Korea, Spain, Taiwan, Ukraine, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedOct 25, 2011
Enrollment StartJul 20, 2012
Primary CompletionMay 27, 2016
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 14.7 years ago

Interventions

Placebodrug

Placebo 10 mg orally (PO) twice a day (BID)

CP690,550drug

CP-690,550 5 mg orally (PO) twice a day (BID)

CP-690,550drug

CP-690,550 10 mg orally (PO) twice a day (BID)