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

Phase 3CompletedNCT02096861

Celltrion220 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

220

Conditions

Crohn's Disease

Interventions

CT-P13BIOLOGICAL

CT-P13 (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

RemicadeBIOLOGICAL

Remicade (5 mg/kg) by intravenous (IV) infusion administered as a 2 hour IV infusion per dose

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nashville Medical Research Institute

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

The Number and Percentage of Patients Achieving Clinical Response According to Crohn's Disease Activity Index (CDAI)-70 Criteria at Week 6

A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more at Week 6 comparing to the baseline value.

Time frame: at Week 6

Secondary Outcomes

The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30

A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.

Time frame: Week 30

The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54

A patient was defined as having a CDAI-70 response if there was a decrease in CDAI score of 70 points or more from the baseline value.

Time frame: Week 54

The Number and Percentage of Patients Achieving Clinical Remission at Week 6

Clinical remission was defined as an absolute CDAI score of less than 150 points.

Time frame: Week 6

The Number and Percentage of Patients Achieving Clinical Remission at Week 30

Clinical remission was defined as an absolute CDAI score of less than 150 points.

Time frame: Week 30

The Number and Percentage of Patients Achieving Clinical Remission at Week 54

Clinical remission was defined as an absolute CDAI score of less than 150 points.

Time frame: Week 54

The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

Data from ClinicalTrials.gov

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