At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 24 enrolled
Drug / intervention
infliximab +1 moredrug
Likely dose
infliximab 5 mg/kgfrom 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.
Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
In Brief
A Phase 4 clinical trial evaluating infliximab and placebo for Crohn's Disease. Completed, enrolled 24 participants across 1 site.
Detailed Summary
A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
CollaboratorsCentocor, Inc.
Timeline
Phase 4CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartJan 2005
First PostedJun 2008
Primary CompletionAug 2008
Study CompletionJan 2009
TodayJul 2026
First PostedJun 3, 2008
Enrollment StartJan 1, 2005
Primary CompletionAug 1, 2008
Study CompletionJan 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 18.1 years ago
Interventions
infliximabdrug
5 mg/kg IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6
placebodrug
placebo IV at baseline, 2 weeks, 6 weeks and then every 8 weeks x 6