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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-UMIN000015297 |
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Date of registration:
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01/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The feasibility study of accelated infliximab infusion from initial administration
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Scientific title:
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The feasibility study of accelated infliximab infusion from initial administration - The feasibility study of accelated infliximab infusion from initial administration |
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Date of first enrolment:
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2012/09/19 |
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Target sample size:
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54 |
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Recruitment status: |
Recruiting |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017799 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Phase II
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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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Yuichi
Takiguchi |
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Address:
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1-8-1, Inohana, Chuo-ku, Chiba
260-8677
Japan |
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Telephone:
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043-222-7171 |
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Email:
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takiguchi@faculty.chiba-u.jp |
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Affiliation:
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Graduate School of Medicine, Chiba University Department of Medical Oncology |
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Name:
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Yuichi
Takiguchi |
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Address:
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1-8-1, Inohana, Chuo-ku, Chiba
Japan |
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Telephone:
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043-222-7171 |
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Email:
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takiguchi@faculty.chiba-u.jp |
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Affiliation:
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Graduate School of Medicine, Chiba University Department of Medical Oncology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1)active serious infection 2)active tuberuculosis infection 3)allergy and/or hypersensitivity for mouse-derived protein 4)demyelinating disease(MS) 5)congestive heart failure 6)pregnant, nursing or likelihood of pregnancy woman 7)unable to birth control during and after 6 months from the latest infliximab administration 8)Not suitable for participating in the study for any other reason
Age minimum:
20years-old
Age maximum:
70years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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patient in whom infliximab is indicated(rheumatoid arthritis, Crohn's disease, Ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis)
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Intervention(s)
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Administration of intravenous infliximab infusion with 60 min accelated procedure for patients who are already successfully treated with usual 2hr infuion without infusion reaction. The tolerable patient continue to receive more five treatment with 60min procedure.
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Primary Outcome(s)
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The incidence of infusion reaction with 60min infliximab accelated infusion
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Secondary Outcome(s)
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discontinuous rate due to infusion reaction success rate of rescue by usual 2hrs infusion after occurrence of infusion reaction evaluation of premedication
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Source(s) of Monetary Support
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Chiba University Hospital
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Ethics review
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Status: YES
Approval date:
Contact:
chibacrc@mac.com
Chiba University Hospital
043-222-7171
chibacrc@mac.com
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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31/03/2015 |
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URL:
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