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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-UMIN000027208 |
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Date of registration:
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01/06/2017 |
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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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A pilot study for the effect of infliximab on endothelial function in patients with psoriasis
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Scientific title:
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A pilot study for the effect of infliximab on endothelial function in patients with psoriasis - The effect of infliximab on endothelial function in patients with psoriasis |
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Date of first enrolment:
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2017/06/01 |
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Target sample size:
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25 |
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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=R000030762 |
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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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Not applicable
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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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Satoshi
Toyama |
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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yasano-tky@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital Dermatology |
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Name:
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Satoshi
Toyama |
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Address:
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7-3-1 Hongo, Bunkyo-ku, Tokyo
113-8655
Japan |
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Telephone:
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03-3815-5411 |
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Email:
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yasano-tky@umin.ac.jp |
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Affiliation:
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The University of Tokyo Hospital Dermatology |
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Key inclusion & exclusion criteria
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Inclusion criteria:
Exclusion criteria: 1. Patients who are treated with other biologics within 3 months 2. Patients treated with cyclosporine within 2 weeks 3. Patients with the past history of severe hypersensitivity or anaphylaxis against infliximab or drugs including murine proteins. 4. Patients with or suspected of having malignancy 5. Patients with serious infection, such as sepsis and positivity of Hepatitis B virus antigen 6. Patients with active or the past history of tuberculosis 7. Patients with active or the past history of demyelinating diseases 8. Patients with congestive heart failure 9. Patients with serious liver diseases (more than 300 IU of AST or ALT) 10. Patients with serious kidney diseases (serum creatinine >= 2.0mg/dl) 11. Patients under or suspected of pregnancy 12. Patients under breast feeding 13. Patients who are regarded to be inappropriate for this study by doctors
Age minimum:
20years-old
Age maximum:
80years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis
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Intervention(s)
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Endothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.
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Primary Outcome(s)
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The percentage improvement in reactive hyperemia index measured by EndoPAT at 4 hours after the third infusion compared with the baseline
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Source(s) of Monetary Support
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Mitsubishi Tanabe Pharma Corporation
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Ethics review
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Status: YES
Approval date: 26/05/2017
Contact:
ethics@m.u-tokyo.ac.jp
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo,Intervention Research Ethics Committee
03-5841-0818
ethics@m.u-tokyo.ac.jp
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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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30/06/2022 |
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URL:
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