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

Sponsor:

Collaborator:

Pfizer

Information provided by (Responsible Party):

Celltrion

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Crohn's Disease	Biological: CT-P13 Biological: Remicade	Phase 3

Study Design

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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

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Infliximab

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Experimental: CT-P13 - CT-P13 CT-P13 followed by CT-P13 from Week 30	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	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	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	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

Outcome Measures

Primary Outcome Measures :

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.

Secondary Outcome Measures :

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.

Eligibility Criteria

Information from the National Library of Medicine

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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

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.

Contacts and Locations

Information from the National Library of Medicine

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

Locations

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United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States, 37205

Sponsors and Collaborators

Celltrion

Pfizer

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Ye BD, Pesegova M, Alexeeva O, Osipenko M, Lahat A, Dorofeyev A, Fishman S, Levchenko O, Cheon JH, Scribano ML, Mateescu RB, Lee KM, Eun CS, Lee SJ, Lee SY, Kim H, Schreiber S, Fowler H, Cheung R, Kim YH. Efficacy and safety of biosimilar CT-P13 compared with originator infliximab in patients with active Crohn's disease: an international, randomised, double-blind, phase 3 non-inferiority study. Lancet. 2019 Apr 27;393(10182):1699-1707. doi: 10.1016/S0140-6736(18)32196-2. Epub 2019 Mar 28.

Husereau D, Feagan B, Selya-Hammer C. Policy Options for Infliximab Biosimilars in Inflammatory Bowel Disease Given Emerging Evidence for Switching. Appl Health Econ Health Policy. 2018 Jun;16(3):279-288. doi: 10.1007/s40258-018-0371-0.

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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

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Studies a U.S. FDA-regulated Drug Product:	Yes
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis Gastrointestinal Diseases Digestive System Diseases	Intestinal Diseases Infliximab Dermatologic Agents Gastrointestinal Agents Antirheumatic Agents

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