At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 614 enrolled
Drug / intervention
tofacitinib +1 moredrug
Likely dose
tofacitinib 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.
A Multicentre, Randomized, Double-blind, Placebo-controlled, Parallel-group Study Of Oral Cp-690,550 As An Induction Therapy In Subjects With Moderate To Severe Ulcerative Colitis
In Brief
A Phase 3 clinical trial evaluating tofacitinib and Placebo for Ulcerative Colitis. Completed, enrolled 614 participants across 178 sites in 28 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesAustralia, Austria, Belgium, Canada, Colombia, Croatia, Czechia, Denmark, Estonia, France, Germany, Hungary, Israel, Italy, Japan, Latvia, Netherlands, New Zealand, Poland, Romania, Russia, Serbia, Slovakia, South Africa, Spain, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 2011
Enrollment StartApr 2012
Primary CompletionMay 2015
TodayJul 2026
First PostedNov 7, 2011
Enrollment StartApr 1, 2012
Primary CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 14.7 years ago
Interventions
tofacitinibdrug
10 mg oral BID
Placebodrug
Plabebo oral BID