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Completed

NCT Number: NCT02096861

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

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.

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Key information

Conditions

Crohn's Disease Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nashville Medical Research Institute

Nashville, Tennessee, 37205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CT-P13

Biological

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

Remicade

Biological

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

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

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

    Time frame: 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.

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

    Time frame: 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.

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

    Time frame: Week 6

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

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

    Time frame: Week 30

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

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

    Time frame: Week 54

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

  6. The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)

    Time frame: Up to Week 30

    SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.

    Higher values of SIBDQ represent a better patient disease outcome.

  7. The Short Inflammatory Bowel Disease Questionnaire

    Time frame: Baseline and Week 54

    SIBDQ is scored with 10 sub-question which can be scored from 1 to 7. Therefore, SIBDQ can be scored from 7 to 70.

    Higher values of SIBDQ represent a better patient disease outcome.

Sponsors and collaborators

Lead sponsor

Celltrion

Industry

Collaborators

  • Pfizer

Registry information

Official study title

A Randomized, Double-Blind, Parallel-Group, Phase 3 Study to Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 Compared to Remicade in Patients With Active Crohn's Disease

Important dates

Study start
2014
Primary completion
2016
Study completion
2017
First posted
Mar 26, 2014
Registry last updated
May 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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