Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
This trial is active, not recruiting.
|Start date||July 2014|
|End date||January 2016|
|Trial size||220 participants|
|Trial identifier||NCT02096861, 2013-004497-10, CT-P13 3.4|
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.
|Endpoint classification||safety/efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, investigator)|
Efficacy evaluated by Assessment of Crohn's disease activity index -70 response
time frame: at Week 6
Male or female participants from 18 years up to 75 years old.
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.
|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|
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