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

NCT02096861 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 220

Last updated 2018-05-09

Study results available
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Summary

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.

Conditions

Interventions

BIOLOGICAL

CT-P13

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

BIOLOGICAL

Remicade

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

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-09-19
Primary Completion
2016-01-11
Completion
2017-02-15
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02096861 on ClinicalTrials.gov