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

Completed · Phase 3

Conditions studied: Crohn's Disease

In brief

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.

Key facts

Study ID

NCT02096861

Run by

Celltrion

People needed

220

Starts

2014-09-19

Expected to finish

2017-02-15

Last updated by the study team

2018-05-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patients with active Crohn's disease and a Crohn's disease activity index score between 220 and 450 points

You may not qualify if…

• 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.

Where it is running

• Nashville Medical Research Institute — Nashville, Tennessee, United States

Full record on ClinicalTrials.gov

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