At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 220 enrolled
Drug / intervention
CT-P13 +1 morebiological
Likely dose
CT-P13 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.
A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease
In Brief
A Phase 3 clinical trial evaluating CT-P13 and Remicade for Crohn's Disease. Completed, enrolled 220 participants across 1 site.
Detailed Summary
This study is to assess noninferiority in efficacy and to assess overall safety of CT P13 compared to Remicade in patients with active Crohn's disease up to Week 54.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn's Disease
CountriesUnited States
CollaboratorsPfizer
Timeline
Phase 3CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMar 2014
Enrollment StartSep 2014
Primary CompletionJan 2016
Study CompletionFeb 2017
TodayJul 2026
First PostedMar 26, 2014
Enrollment StartSep 19, 2014
Primary CompletionJan 11, 2016
Study CompletionFeb 15, 2017
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 12.3 years ago
Interventions
CT-P13biological
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Remicadebiological
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose