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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: 25 February 2020
Main ID:  JPRN-jRCTs031180367
Date of registration: 18/03/2019
Prospective Registration: No
Primary sponsor: ASANO YOSHIHIDE
Public title: 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
Date of first enrolment: 20/02/2018
Target sample size: 25
Recruitment status: Recruiting
URL:  https://jrct.niph.go.jp/latest-detail/jRCTs031180367
Study type:  Interventional
Study design:  single arm study, open(masking not used), no treatment control, single assignment, treatment purpose  
Phase:  N/A
Countries of recruitment
Japan
Contacts
Name: YOSHIHIDE    ASANO
Address:  7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655 Tokyo Japan
Telephone: +81-3-5800-8661
Email: yasano-tky@umin.ac.jp
Affiliation:  The University of Tokyo Hospital
Name: YOSHIHIDE    ASANO
Address:  7-3-1 Hongo, Bunkyo-ku, Tokyo, Japan 113-8655 Tokyo Japan
Telephone: +81-3-5800-8661
Email: yasano-tky@umin.ac.jp
Affiliation:  The University of Tokyo Hospital
Key inclusion & exclusion criteria
Inclusion criteria: 1. Patients diagnosed as having psoriasis vulgaris, psoriatic arthritis, pustular psoriasis, erythrodermic psoriasis
2. Patients at the age of 20 - 80 years when written informed consent is obtained
3. Patients who meet either of the following two criteria; (i) insufficiently treated with systemic therapies including phototherapy and skin lesions covering more than 10% of body surface area, (ii) severe skin and joint symptoms refractory to pre-existing treatments and quality of life is highly disturbed.
4. Patients from whom written informed consent is obtained after the sufficient explanation and understanding of this study

Exclusion criteria: 1. Patients who are treated with other biologics (including infliximab) 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: >= 20age old
Age maximum: < 80age old
Gender: Both
Health Condition(s) or Problem(s) studied
D011565, D015535
Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis
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)
The percentage improvement in reactive hyperemia index measured by EndoPAT at 4 hours after the first, second and third infusions compared with the baselines before each infusion
The percentage improvement in Psoriasis Area and Severity Index (PASI) score after the second and third infusions compared with the baseline
Systolic and diastolic blood pressure before the first, second, and third infusions and 8 weeks after the third infusion
HbA1c before the first, second, and third infusions and 8 weeks after the third infusion
T-chol, LDL, HDL and TG before the first, second, and third infusions and 8 weeks after the third infusion
High-sensitivity CRP before the first, second, and third infusions and 8 weeks after the third infusion
Serum levels of infliximab and anti-infliximab antibody before the first and third infusions
Secondary ID(s)
UMIN000027208
Source(s) of Monetary Support
Mitsubishi Tanabe Pharma Corporation
Secondary Sponsor(s)
Ethics review
Status: Approval
Approval date: 28/02/2019
Contact:
ethics@m.u-tokyo.ac.jp
The University of Tokyo, Clinical Research Review Board
+81-3-5841-0818
ethics@m.u-tokyo.ac.jp
Results
Results available:
Date Posted:
Date Completed:
URL:
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