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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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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000027465 |
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Date of registration:
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24/05/2017 |
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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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Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis
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Scientific title:
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Efficacy and safety of the biosimilar Infliximab in the patients with ulcerative colitis - Efficacy and safety of IFX-BS in UC patients |
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Date of first enrolment:
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2017/05/29 |
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Target sample size:
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20 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031466 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Sohachi Nanjo |
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Address:
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Sugitani 2630, Toyama City, Toyama Prefecture, Japan
Japan |
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Telephone:
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076-434-7301 |
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Email:
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snanjo@med.u-toyama.ac.jp |
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Affiliation:
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University of Toyama Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Scienc |
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Name:
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Sohachi Nanjo |
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Address:
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Sugitani 2630, Toyama City, Toyama Prefecture, Japan
Japan |
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Telephone:
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076-434-7301 |
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Email:
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snanjo@med.u-toyama.ac.jp |
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Affiliation:
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University of Toyama Department of Gastroenterology and Hematology, Graduate School of Medicine and Pharmaceutical Sciences |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1) Patients younger than 20 years old 2) Patients keeping in the clinical remission state for more than 10 years
Age minimum:
20years-old
Age maximum:
Not applicable
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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ulcerative colitis
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Intervention(s)
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Infliximab (5mg/kg, every 8 weeks, for 12 months)
Biosimilar Infliximab (5mg/kg, every 8 weeks, for 12 months)
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Primary Outcome(s)
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The remission rate and the adverse events 24 and 48 weeks after the switch from infliximab to its biosimilar
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Secondary Outcome(s)
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The value of partial Mayo's score The value of serum CRP The value of serum albumin The value of hemoglobin The increase of Infliximab or biosimilar Infliximab
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Source(s) of Monetary Support
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plural commercial corporations
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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31/12/2018 |
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URL:
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