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

Crohn's Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02096861
• Other study ID #: CT-P13 3.4
• Secondary ID: 2013-004497-10
• Status: Completed
• Phase: Phase 3
• Start date: September 19, 2014
• Est. completion date: February 15, 2017

Study information

• Verified date: March 2018
• Source: Celltrion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: February 15, 2017
• Est. primary completion date: January 11, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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 and/or a Tumor necrosis factor (TNF)-alpha inhibitor for the treatment of other 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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

Biological:
• 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

Locations

Country	Name	City	State
United States	Nashville Medical Research Institute	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Celltrion	Pfizer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6	A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.	at Week 6
Secondary	The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30	A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.	Week 30
Secondary	The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54	A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.	Week 54
Secondary	The Number and Percentage of Patients Achieving Clinical Remission at Week 6	Clinical remission was defined as an absolute CDAI score of less than 150 points.	Week 6
Secondary	The Number and Percentage of Patients Achieving Clinical Remission at Week 30	Clinical remission was defined as an absolute CDAI score of less than 150 points.	Week 30
Secondary	The Number and Percentage of Patients Achieving Clinical Remission at Week 54	Clinical remission was defined as an absolute CDAI score of less than 150 points.	Week 54
Secondary	The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.; Higher values of SIBDQ represent a better patient disease outcome.	Up to Week 30
Secondary	The Short Inflammatory Bowel Disease Questionnaire	SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.; Higher values of SIBDQ represent a better patient disease outcome.	Baseline and Week 54