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

Celltrion Healthcare

Status and phase: Completed; Phase 3

Conditions: Crohn's Disease

Treatments: Biological: Remicade; Biological: CT-P13

Study type: Interventional

Funder types: Industry

Identifiers

NCT02096861

2013-004497-10 (EudraCT Number)

CT-P13 3.4

Details and patient eligibility

About

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.

Enrollment: 220 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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220 participants in 4 patient groups

CT-P13 - CT-P13

Experimental group

Description:

CT-P13 followed by CT-P13 from Week 30

Treatment:

Biological: CT-P13

CT-P13 - Remicade

Active Comparator group

Description:

CT-P13 followed by Remicade from Week 30

Treatment:

Biological: Remicade

Biological: CT-P13

Remicade - Remicade

Active Comparator group

Description:

Remicade followed by Remicade from Week 30

Treatment:

Biological: Remicade

Remicade - CT-P13

Experimental group

Description:

Remicade followed by CT-P13 from Week 30

Treatment:

Biological: Remicade

Biological: CT-P13