UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027208 |
|---|---|
| Receipt number | 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 | 2021/12/08 14:16:32 |
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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 | Satoshi |
| Middle name | |
| Last name | Toyama |
Organization
The University of Tokyo Hospital
Division name
Dermatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
yasano-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Toyama |
Organization
The University of Tokyo Hospital
Division name
Dermatology
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
03-3815-5411
Homepage URL
yasano-tky@umin.ac.jp
Sponsor or person
Institute
The University of Tokyo Hospital
Institute
Department
Personal name
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
Graduate School of Medicine and Faculty of Medicine, The University of Tokyo,Intervention Research Ethics Committee
Address
7-3-1,Hongo,Bunkyo-ku,Tokyo
Tel
03-5841-0818
ethics@m.u-tokyo.ac.jp
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
| 2017 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
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
| 2021 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030762
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| Registered date | File name |
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