At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 268 enrolled
Drug / intervention
PF-00547659drug
Likely dose
PF-00547659 75 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 Multicenter Open-label Extension Study To Assess Long-term Safety Of PF-00547659 In Subjects With Crohn's Disease OPERA II
In Brief
A Phase 2 clinical trial evaluating PF-00547659 for Crohn's Disease. Completed, enrolled 268 participants across 112 sites in 15 countries.
Detailed Summary
This study provides open-label drug to eligible patients who have completed a prior study of PF-00547659. The primary endpoint for this study is long-term safety.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesAustria, Belgium, Canada, France, Germany, Japan, Netherlands, Norway, Poland, Serbia, Slovakia, South Africa, South Korea, Spain, United States
Collaborators--
Timeline
Phase 2CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 2011
Enrollment StartJul 2011
Primary CompletionJul 2016
TodayJul 2026
First PostedFeb 17, 2011
Enrollment StartJul 1, 2011
Primary CompletionJul 27, 2016
TodayJul 2, 2026
Enrollment to primary: 5.1 yearsPosted 15.4 years ago
Interventions
PF-00547659drug
75 mg SC once monthly for 72 weeks. Subjects may escalate to 225 mg or de-escalate to 22.5 mg one time.