Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
NCT02096861
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
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1-800-718-1021
- Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points
- 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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Descriptive Information | |||||
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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 |
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Study Arms ICMJE |
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Publications * |
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* 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 | 220 | ||||
Original Estimated Enrollment ICMJE | 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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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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 |