Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
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ClinicalTrials.gov Identifier: NCT02096861 |
Recruitment Status :
Completed
First Posted : March 26, 2014
Results First Posted : April 11, 2018
Last Update Posted : May 9, 2018
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Crohn's Disease | Biological: CT-P13 Biological: Remicade | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 220 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 19, 2014 |
Actual Primary Completion Date : | January 11, 2016 |
Actual Study Completion Date : | February 15, 2017 |

Arm | Intervention/treatment |
---|---|
Experimental: CT-P13 - CT-P13
CT-P13 followed by CT-P13 from Week 30
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Biological: CT-P13
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
Active Comparator: CT-P13 - Remicade
CT-P13 followed by Remicade from Week 30
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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 |
Active Comparator: Remicade - Remicade
Remicade followed by Remicade from Week 30
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Biological: Remicade
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose |
Experimental: Remicade - CT-P13
Remicade followed by CT-P13 from Week 30
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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 |
- The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6 [ Time Frame: 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.
- The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30 [ Time Frame: 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 Response According to CDAI-70 Criteria at Week 54 [ Time Frame: 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 Number and Percentage of Patients Achieving Clinical Remission at Week 6 [ Time Frame: 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 30 [ Time Frame: Week 30 ]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 [ Time Frame: Week 54 ]Clinical remission was defined as an absolute CDAI score of less than 150 points.
- The Short Inflammatory Bowel Disease Questionnaire (SIBDQ) [ Time Frame: 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 Short Inflammatory Bowel Disease Questionnaire [ Time Frame: 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.

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Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02096861
United States, Tennessee | |
Nashville Medical Research Institute | |
Nashville, Tennessee, United States, 37205 |
Responsible Party: | Celltrion |
ClinicalTrials.gov Identifier: | NCT02096861 |
Other Study ID Numbers: |
CT-P13 3.4 2013-004497-10 ( EudraCT Number ) |
First Posted: | March 26, 2014 Key Record Dates |
Results First Posted: | April 11, 2018 |
Last Update Posted: | May 9, 2018 |
Last Verified: | March 2018 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases |
Intestinal Diseases Infliximab Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents |