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

Phase 3

Completed

• Conditions: Crohn's Disease
• Interventions: Biological: CT-P13; Biological: Remicade

• Registration Number: NCT02096861
• Lead Sponsor: Celltrion

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-24
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-26
• Study Start: 2014-09-19
• Primary Completion: 2016-01-11
• Study Completion: 2017-02-15
• Results First Submitted: 2018-02-14
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-15
• Last Update Submitted: 2018-04-10
• Results First Posted: 2018-04-11
• Last Update Posted: 2018-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 220

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CT-P13 - CT-P13	CT-P13	CT-P13 followed by CT-P13 from Week 30
CT-P13 - Remicade	CT-P13	CT-P13 followed by Remicade from Week 30
Remicade - Remicade	Remicade	Remicade followed by Remicade from Week 30
Remicade - CT-P13	CT-P13	Remicade followed by CT-P13 from Week 30
Remicade - CT-P13	Remicade	Remicade followed by CT-P13 from Week 30
CT-P13 - Remicade	Remicade	CT-P13 followed by Remicade from Week 30

Primary Outcome Measures

Name	Time	Method
The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6	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.

Secondary Outcome Measures

Name	Time	Method
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54	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.
The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)	Up to Week 30	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.
The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30	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.
The Number and Percentage of Patients Achieving Clinical Remission at Week 6	Week 6	Clinical remission was defined as an absolute CDAI score of less than 150 points.
The Number and Percentage of Patients Achieving Clinical Remission at Week 54	Week 54	Clinical remission was defined as an absolute CDAI score of less than 150 points.
The Number and Percentage of Patients Achieving Clinical Remission at Week 30	Week 30	Clinical remission was defined as an absolute CDAI score of less than 150 points.
The Short Inflammatory Bowel Disease Questionnaire	Baseline and Week 54	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.

Trial Locations

Locations (1)

Nashville Medical Research Institute; 🇺🇸 Nashville, Tennessee, United States