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

April 10, 2018 updated by: Celltrion

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

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
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.
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
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.
Week 30
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.
Week 54
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.
Week 6
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.
Week 30
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.
Week 54
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.
Up to Week 30
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.
Baseline and Week 54

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celltrion

Collaborators

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 19, 2014

Primary Completion (Actual)

January 11, 2016

Study Completion (Actual)

February 15, 2017

Study Registration Dates

First Submitted

March 24, 2014

First Submitted That Met QC Criteria

March 24, 2014

First Posted (Estimate)

March 26, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2018

Last Update Submitted That Met QC Criteria

April 10, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT-P13 3.4
  • 2013-004497-10 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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