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. |
Register:
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JPRN |
Last refreshed on:
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17 October 2023 |
Main ID: |
JPRN-UMIN000007806 |
Date of registration:
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01/05/2012 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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The feasibility study of accelated infliximab infusion during maintenance phase
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Scientific title:
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The feasibility study of accelated infliximab infusion during maintenance phase - The feasibility study of accelated infliximab infusion during maintenance phase |
Date of first enrolment:
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2012/06/01 |
Target sample size:
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54 |
Recruitment status: |
Complete: follow-up complete |
URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009195 |
Study type:
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Interventional |
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 |
Address:
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1-8-1, Inohana, Chuo-ku, Chiba
Japan |
Telephone:
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043-222-7171 |
Email:
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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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Emiko Sakaida |
Address:
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1-8-1, Inohana, Chuo-ku, Chiba
Japan |
Telephone:
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043-222-7171 |
Email:
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esakaida@faculty.chiba-u.jp |
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)past history of bronchial asthma 4)past history of hypersensitivity reaction and/or allergy for any drugs and food 5)allergy and/or hypersensitivity for mouse-derived protein 6)demyelinating disease(MS) 7)congestive heart failure 8)pregnant, nursing or likelihood of pregnancy woman 9)unable to birth control during and after 6 months from the latest infliximab administration 10)past treatment history with infliximab and readministration at an interval of over three months 11)Not suitable for participating in the study for any other reason
Age minimum:
Not applicable
Age maximum:
Not applicable
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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1) patients preference 2) discontinuous rate due to infusion reaction 3) success rate of rescue by usual 2hrs infusion after occurrence of infusion reaction 4) evaluation of premedication
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Source(s) of Monetary Support
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None
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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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Yes |
Date Posted:
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Date Completed:
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01/12/2014 |
URL:
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