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

NCT02096861

Last updated date
Study Location
Nashville Medical Research Institute
Nashville, Tennessee, 37205, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: CT-P13 - CT-P13
    CT-P13 followed by CT-P13 from Week 30
    Intervention: Biological: CT-P13
  • Active Comparator: CT-P13 - Remicade
    CT-P13 followed by Remicade from Week 30
    Interventions:
    • Biological: CT-P13
    • Biological: Remicade
  • Active Comparator: Remicade - Remicade
    Remicade followed by Remicade from Week 30
    Intervention: Biological: Remicade
  • Experimental: Remicade - CT-P13
    Remicade followed by CT-P13 from Week 30
    Interventions:
    • Biological: CT-P13
    • Biological: Remicade
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 11, 2016)
220
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2014)
214
Actual Study Completion Date  ICMJE February 15, 2017
Actual Primary Completion Date January 11, 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02096861
Other Study ID Numbers  ICMJE CT-P13 3.4
2013-004497-10 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Celltrion
Study Sponsor  ICMJE Celltrion
Collaborators  ICMJE Pfizer
Investigators  ICMJE Not Provided
PRS Account Celltrion
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP