NCT02096861

Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (actual)
• Sponsor: Celltrion · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn's Disease

Interventions

Type	Name	Description
BIOLOGICAL	CT-P13	CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
BIOLOGICAL	Remicade	Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

Timeline

• Start date: 2014-09-19
• Primary completion: 2016-01-11
• Completion: 2017-02-15
• First posted: 2014-03-26
• Last updated: 2018-05-09
• Results posted: 2018-04-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study