Trial record 3 of 6 for:    ct-p13

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Celltrion
Sponsor:
Collaborator:
Hospira, Inc.
Information provided by (Responsible Party):
Celltrion
ClinicalTrials.gov Identifier:
NCT02096861
First received: March 24, 2014
Last updated: July 23, 2014
Last verified: July 2014
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 214
Study Start Date: July 2014
Estimated Study Completion Date: March 2017
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02096861

Contacts
Contact: BoYoung Choi BoYoung.Choi@celltrion.com

Locations
United States, Tennessee
Nashville Medical Research Institute Recruiting
Nashville, Tennessee, United States
Contact: Pruitt Ronald         
Sponsors and Collaborators
Celltrion
Hospira, Inc.
  More Information

No publications provided

Responsible Party: Celltrion
ClinicalTrials.gov Identifier: NCT02096861     History of Changes
Other Study ID Numbers: CT-P13 3.4, 2013-004497-10
Study First Received: March 24, 2014
Last Updated: July 23, 2014
Health Authority: Korea: Ministry of Food and Drug Safety
United States: Food and Drug Administration

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on August 28, 2014