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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: |
NCT02883452 |
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Date of registration:
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25/08/2016 |
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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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A Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety of CT-P13 Subcutaneous in Patients With Active Crohn's Disease and Ulcerative Colitis
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Scientific title:
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An Open-label, Randomized, Parallel-Group, Phase I Study to Evaluate Pharmacokinetics, Efficacy and Safety Between Subcutaneous CT-P13 and Intravenous CT-P13 in Patients With Active Crohn's Disease and Active Ulcerative Colitis |
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Date of first enrolment:
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September 29, 2016 |
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Target sample size:
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181 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02883452 |
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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: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Korea, Republic of
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Contacts
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Name:
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MoonSun Choi |
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Address:
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Telephone:
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Email:
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Affiliation:
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Celltrion |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patient has active Crohn's disease with a score on the Crohn's disease activity index
between 220 and 450 points.
- Patient has active Ulcerative colitis as defined by a total Mayo score between 6 and
12 points (Part 2 only).
Exclusion Criteria:
- Patient who has previously received a biological agent for the treatment of CD and UC
and/or a tumor necrosis factor-alpha (TNFa) inhibitor for the treatment of other
disease
- Patient who has allergies to any of the excipients of infliximab or any other murine
and/or human proteins or patient with a hypersensitivity to immunoglobulin product
- Patient who has a current or past history of infection with HIV, hepatitis B, or
hepatitis C (carriers of hepatitis B and hepatitis C are not permitted to enrol into
the study, but past hepatitis B resolved can be enrolled)
- Patient who has acute infection requiring oral antibiotics within 2 weeks or
parenteral injection of antibiotics within 4 weeks prior to the first administration
of the study drug, other serious infection within 6 months prior to the first
administration of study drug or recurrent herpes zoster or other chronic or recurrent
infection within 6 weeks prior to the first administration of the study drug
- Patient who has an indeterminate result for interferon-? release assay (IGRA) or
latent tuberculosis (TB) at Screening. For Part 2, if IGRA result is indeterminate at
Screening, 1 retest will be possible during the screening. If the repeated IGRA result
is negative, the patient can be included in the study.
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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Ulcerative Colitis (Part 2 Only)
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Crohn's Disease
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Intervention(s)
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Biological: CT-P13
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Primary Outcome(s)
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Analysis of Covariance Model (ANCOVA) of Observed Ctrough,week22 (Pre-dose Level at Week 22) (Part 2)
[Time Frame: Week 22]
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Descriptive Statistics of Area Under the Concentration-time Curve (AUCt) of Infliximab at Steady State (Part 1)
[Time Frame: Week 22, 24, 26 and 28]
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Secondary Outcome(s)
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Descriptive Statistics for Actual Value of Partial Mayo Score (Part 2 - UC)
[Time Frame: up to Week 54]
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Descriptive Statistics for Actual Value in Fecal Calprotectin Concentration (Pharmacodynamic Parameter) (Part 2)
[Time Frame: up to Week 54]
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Descriptive Statistics for Actual Value of Crohn's Disease Activity Index (CDAI) Score (Part 2 - CD)
[Time Frame: up to Week 54]
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Descriptive Statistics of Observed Ctrough (Trough Concentration [Before the Next Study Drug Administration]) of Infliximab (Part 2)
[Time Frame: up to Week 54]
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Proportion of Patients Achieving Clinical Response According to CDAI-100 Criteria (Part 2 - CD)
[Time Frame: up to Week 54]
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Proportion of Patients Achieving Clinical Response According to the Partial Mayo Score (Part 2 - UC)
[Time Frame: up to Week 54]
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Secondary ID(s)
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CT-P13 1.6 (SC)
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2016-002124-89
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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