Overview

This trial is active, not recruiting.

Condition crohn's disease
Treatments ct-p13, remicade
Phase phase 3
Target TNF-alpha
Sponsor Celltrion
Collaborator Hospira, Inc.
Start date July 2014
End date January 2016
Trial size 220 participants
Trial identifier NCT02096861, 2013-004497-10, CT-P13 3.4

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
ct-p13
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
(Experimental)
ct-p13
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
remicade
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
(Active Comparator)
remicade
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
(Active Comparator)
ct-p13
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
remicade
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

Primary Outcomes

Measure
Efficacy evaluated by Assessment of Crohn's disease activity index -70 response
time frame: at Week 6

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points Exclusion Criteria: - Patient who has previously received a biological agent for the treatment of Crohn's disease. - Patient who has allergies to any of the excipients of infliximab, any other murine and/or human proteins, or patient with a hypersensitivity to immunoglobulin product.

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by Celltrion.