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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027208
Receipt No. R000030762
Scientific Title A pilot study for the effect of infliximab on endothelial function in patients with psoriasis
Date of disclosure of the study information 2017/06/01
Last modified on 2017/11/01

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Basic information
Public title A pilot study for the effect of infliximab on endothelial function in patients with psoriasis
Acronym 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
Scientific Title:Acronym The effect of infliximab on endothelial function in patients with psoriasis
Region
Japan

Condition
Condition Psoriasis vulgaris, Psoriatic arthritis, Pustular psoriasis, Erythrodermic psoriasis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To elucidate whether infliximab improves endothelial function in patients with psoriasis
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The percentage improvement in reactive hyperemia index measured by EndoPAT at 4 hours after the third infusion compared with the baseline
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Endothelial function is measured in patients with psoriasis treated with infliximab before and after the first, second, and third infusions.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key 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
Key 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
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yoshihide Asano
Organization The University of Tokyo Hospital
Division name Dermatology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Email yasano-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshihide Asano
Organization The University of Tokyo Hospital
Division name Dermatology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL 03-3815-5411
Homepage URL
Email yasano-tky@umin.ac.jp

Sponsor
Institute The University of Tokyo Hospital
Institute
Department

Funding Source
Organization Mitsubishi Tanabe Pharma Corporation
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2017 Year 06 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Open public recruiting
Date of protocol fixation
2017 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 05 Month 01 Day
Last modified on
2017 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030762

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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