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

Primary Purpose

Crohn's Disease

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
CT-P13
Remicade
Sponsored by
Celltrion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn's Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nashville Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Experimental

Arm Label

CT-P13 - CT-P13

CT-P13 - Remicade

Remicade - Remicade

Remicade - CT-P13

Arm Description

CT-P13 followed by CT-P13 from Week 30

CT-P13 followed by Remicade from Week 30

Remicade followed by Remicade from Week 30

Remicade followed by CT-P13 from Week 30

Outcomes

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
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
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
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
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
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
Clinical remission was defined as an absolute CDAI score of less than 150 points.
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.
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.

Full Information

First Posted
March 24, 2014
Last Updated
April 10, 2018
Sponsor
Celltrion
Collaborators
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT02096861
Brief Title
Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
September 19, 2014 (Actual)
Primary Completion Date
January 11, 2016 (Actual)
Study Completion Date
February 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Celltrion
Collaborators
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
220 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Nashville Medical Research Institute
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
35435862
Citation
Narula N, Wong ECL, Dulai PS, Marshall JK, Jairath V, Reinisch W. Comparative Effectiveness of Biologics for Endoscopic Healing of the Ileum and Colon in Crohn's Disease. Am J Gastroenterol. 2022 Jul 1;117(7):1106-1117. doi: 10.14309/ajg.0000000000001795. Epub 2022 Apr 15.
Results Reference
derived
PubMed Identifier
34216825
Citation
Dulai PS, Wong ECL, Reinisch W, Narula N. Clinical Decision Support Tool for Infliximab in Crohn's Disease. Clin Gastroenterol Hepatol. 2022 May;20(5):e1192-e1195. doi: 10.1016/j.cgh.2021.06.037. Epub 2021 Jun 30.
Results Reference
derived
PubMed Identifier
33245751
Citation
Wong ECL, Buffone E, Lee SJ, Dulai PS, Marshall JK, Reinisch W, Narula N. End of Induction Patient-reported Outcomes Predict Clinical Remission but Not Endoscopic Remission in Crohn's Disease. J Crohns Colitis. 2021 Jul 5;15(7):1114-1119. doi: 10.1093/ecco-jcc/jjaa242.
Results Reference
derived
PubMed Identifier
30929895
Citation
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.
Results Reference
derived
PubMed Identifier
29411318
Citation
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.
Results Reference
derived

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

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