Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 5/11/2018 |
| Start Date: | September 19, 2014 |
| End Date: | February 15, 2017 |
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
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.
compared to Remicade in patients with active Crohn's disease up to Week 54.
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.
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