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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: JPRN
Last refreshed on: 15 June 2020
Main ID:  JPRN-UMIN000027208
Date of registration: 01/06/2017
Prospective Registration: Yes
Primary sponsor: The University of Tokyo Hospital
Public title: A pilot study for the effect of infliximab on endothelial function in patients with psoriasis
Scientific title: 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
Date of first enrolment: 2017/06/01
Target sample size: 25
Recruitment status: Recruiting
URL:  https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030762
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not applicable
Countries of recruitment
Japan
Contacts
Name: Yoshihide    Asano
Address:  7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 Japan
Telephone: 03-3815-5411
Email: yasano-tky@umin.ac.jp
Affiliation:  The University of Tokyo Hospital Dermatology
Name: Yoshihide    Asano
Address:  7-3-1 Hongo, Bunkyo-ku, Tokyo Japan
Telephone: 03-3815-5411
Email: yasano-tky@umin.ac.jp
Affiliation:  The University of Tokyo Hospital Dermatology
Key inclusion & exclusion criteria
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
Health Condition(s) or Problem(s) studied
Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis
Intervention(s)
Endothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.
Primary Outcome(s)
The percentage improvement in reactive hyperemia index measured by EndoPAT at 4 hours after the third infusion compared with the baseline
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Mitsubishi Tanabe Pharma Corporation
Secondary Sponsor(s)
Ethics review
Status: YES
Approval date:
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
Results
Results available:
Date Posted:
Date Completed:
URL:
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