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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

220 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-19

Study Completion Date

2017-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Post-Marketing Use Of CT-P13 (Infliximab) For Standard Of Care Treatment Of Inflammatory Bowel Disease

NCT02539368

Inflammatory Bowel Diseases Ulcerative Colitis Crohn's Disease

COMPLETED

CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)

NCT03945019

Crohn's Disease

COMPLETED PHASE3

A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis

NCT02883452

Crohn's Disease Ulcerative Colitis (Part 2 Only)

COMPLETED PHASE1

Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144

NCT02403323

Crohn Disease

TERMINATED PHASE3

An Efficacy and Safety Study of Anti-TNF Monoclonal Antibody in Patients With Crohn's Disease

NCT00269854

Crohn Disease

COMPLETED PHASE2/PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Crohn's Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CT-P13 - CT-P13

CT-P13 followed by CT-P13 from Week 30

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

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

CT-P13 - Remicade

CT-P13 followed by Remicade from Week 30

Group Type ACTIVE_COMPARATOR

CT-P13

Intervention Type BIOLOGICAL

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

Remicade

Intervention Type BIOLOGICAL

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

Remicade - Remicade

Remicade followed by Remicade from Week 30

Group Type ACTIVE_COMPARATOR

Remicade

Intervention Type BIOLOGICAL

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

Remicade - CT-P13

Remicade followed by CT-P13 from Week 30

Group Type EXPERIMENTAL

CT-P13

Intervention Type BIOLOGICAL

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

Remicade

Intervention Type BIOLOGICAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CT-P13

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

Intervention Type BIOLOGICAL

Remicade

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

Intervention Type BIOLOGICAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No