CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 265 enrolled
Drug / intervention
PF-00547659 SC injection +3 moredrug
Likely dose
Not stated in 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/NCT01276509
NCT01276509Phase 2Completed
CompareCT.gov

A Double-blind, Randomized, Placebo-controlled, Dose-ranging Study To Evaluate The Efficacy And Safety Of Pf-00547659 In Subjects With Crohn's Disease (Opera)

Shire·interventional·Posted Jan 13, 2011·Updated Jun 3, 2021

In Brief

A Phase 2 clinical trial evaluating PF-00547659 SC injection for Crohn's Disease. Completed, enrolled 265 participants across 137 sites in 16 countries.

Detailed Summary

Adults with Crohn's disease that is clinically active despite conventional treatment will be eligible for this study. Patients may receive one of three doses of PF-00547659 (experimental drug) or placebo (inactive drug). Disease activity will be measured every two weeks.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustria, Belgium, Bulgaria, Canada, France, Germany, Japan, Netherlands, Norway, Poland, Serbia, Slovakia, South Africa, South Korea, Spain, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedJan 13, 2011
Enrollment StartApr 6, 2011
Primary CompletionFeb 7, 2014
Study CompletionOct 9, 2015
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 15.5 years ago

Interventions

PF-00547659 SC injectiondrug

Placebo delivered SC, 3 doses separated by 4 weeks

PF-00547659 SC injectiondrug

Drug dose level 1 delivered SC, 3 doses separated by 4 weeks

PF-00547659 SC injectiondrug

Drug dose level 2 delivered SC, 3 doses separated by 4 weeks

PF-00547659 SC injectiondrug

Drug dose level 3 delivered SC, 3 doses separated by 4 weeks