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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02096861 |
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Date of registration:
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24/03/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Demonstrate Noninferiority in Efficacy and to Assess Safety of CT-P13 in Patients With Active Crohn's Disease
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Scientific title:
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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 |
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Date of first enrolment:
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September 19, 2014 |
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Target sample size:
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220 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02096861 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 3
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Crohn's Disease
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Intervention(s)
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Biological: CT-P13
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Biological: Remicade
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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The Number and Percentage of Patients Achieving Clinical Remission at Week 6
[Time Frame: Week 6]
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The Short Inflammatory Bowel Disease Questionnaire
[Time Frame: Baseline and Week 54]
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The Number and Percentage of Patients Achieving Clinical Remission at Week 54
[Time Frame: Week 54]
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The Number and Percentage of Patients Achieving Clinical Remission at Week 30
[Time Frame: Week 30]
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The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 30
[Time Frame: Week 30]
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The Number and Percentage of Patients Achieving Clinical Response According to CDAI-70 Criteria at Week 54
[Time Frame: Week 54]
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The Short Inflammatory Bowel Disease Questionnaire (SIBDQ)
[Time Frame: Up to Week 30]
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Secondary ID(s)
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2013-004497-10
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CT-P13 3.4
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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