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Trial record 3 of 12 for:    ct-p13

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02096861
First Posted: March 26, 2014
Last Update Posted: March 29, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Pfizer
Information provided by (Responsible Party):
Celltrion
  Purpose
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 Intervention Phase
Crohn's Disease Biological: CT-P13 Biological: Remicade Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Celltrion:

Primary Outcome Measures:
  • Efficacy evaluated by Assessment of Crohn's disease activity index -70 response [ Time Frame: at Week 6 ]

Enrollment: 220
Study Start Date: July 2014
Study Completion Date: February 15, 2017
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CT-P13 Biological: CT-P13
CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Experimental: CT-P13, switch to Remicade 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 Biological: Remicade
Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose
Active Comparator: Remicade, switch to CT-P13 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
  • 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
United States, Tennessee
Nashville Medical Research Institute
Nashville, Tennessee, United States
Sponsors and Collaborators
Celltrion
Pfizer
  More Information

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02096861     History of Changes
Other Study ID Numbers: CT-P13 3.4
2013-004497-10 ( EudraCT Number )
First Submitted: March 24, 2014
First Posted: March 26, 2014
Last Update Posted: March 29, 2017
Last Verified: March 2017

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents