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

Study Overview
=================
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.

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

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Biological: CT-P13
* Biological: Remicade


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CT-P13 - CT-P13<br>CT-P13 followed by CT-P13 from Week 30 | Biological: CT-P13<br>* CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose<br>|
| Active Comparator: CT-P13 - Remicade<br>CT-P13 followed by Remicade from Week 30 | Biological: CT-P13<br>* CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose<br>Biological: Remicade<br>* Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose<br>|
| Active Comparator: Remicade - Remicade<br>Remicade followed by Remicade from Week 30 | Biological: Remicade<br>* Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose<br>|
| Experimental: Remicade - CT-P13<br>Remicade followed by CT-P13 from Week 30 | Biological: CT-P13<br>* CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose<br>Biological: Remicade<br>* Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |