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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042865
Receipt No. R000048927
Scientific Title A study on the treatments and flare frequency of patients with GPP in Japan, and human genome and genetic analysis to research for genetic mutations : Assessment of treatments, flare frequency and research for novel genetic mutations involved in the pathogenesis of GPP
Date of disclosure of the study information 2021/01/04
Last modified on 2020/12/28

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Basic information
Public title A study on the treatments and flare frequency of patients with GPP in Japan, and human genome and genetic analysis to research for genetic mutations
: Assessment of treatments, flare frequency and research for novel genetic mutations involved in the pathogenesis of GPP
Acronym A study on the treatments and flare frequency of patients with GPP in Japan, and human genome and genetic analysis to research for genetic mutations
Scientific Title A study on the treatments and flare frequency of patients with GPP in Japan, and human genome and genetic analysis to research for genetic mutations
: Assessment of treatments, flare frequency and research for novel genetic mutations involved in the pathogenesis of GPP
Scientific Title:Acronym A study on the treatments and flare frequency of patients with GPP in Japan, and human genome and genetic analysis to research for genetic mutations
Region
Japan

Condition
Condition Generalized pustular psoriasis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information YES

Objectives
Narrative objectives1 Primary Objectives;
To describe the frequency and severity of acute GPP flares under the current treatments for GPP in the real-world clinical practice in Japan
Basic objectives2 Others
Basic objectives -Others Secondary Objectives:
To describe the patients' demographics and the treatments for GPP

Exploratory Objectives:
1) To describe the relationship between biological agents and frequency and severity of acute GPP flares
2) To describe psoriasis related concomitant disease, especially PV (psoriasis vulgaris) and PsA (psoriatic arthritis)
3) To describe and explore the GPP relevant gene
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1) Frequency of acute GPP flares
2) Severity of acute GPP flares
Key secondary outcomes

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients who have been diagnosed with GPP based on the 2006 JDA criteria within 10 years of the date of each ERC approval

2)Patients who had at least 6 months or more continuous observation at the study sites within 10 years of the date of each ERC approval

3)Patients who have obtained written consent for this study from the patient or proxy
However, patients who are unlikely to visit the hospital due to death or transfer to another hospital may only participate in the retrospective study under an opt-out
Key exclusion criteria 1)Patients participating in clinical trials for medical devices or drugs at the time of enrolment in this study

2)Patients who have participated in clinical trial for medical device or drugs prior to enrolment in this study. However, if the products are in approved dosage and administration, it does not meet
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Akimichi
Middle name
Last name Morita
Organization Nagoya City University Graduate School of Medical Sciences
Division name Department of Geriatric and Environmental Dermatology
Zip code 467-8601
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan.
TEL 052-851-5511
Email amorita@med.nagoya-cu.ac.jp

Public contact
Name of contact person
1st name Hayato
Middle name
Last name Konishi
Organization MEBIX INC.
Division name CLINICAL OPERATIONS
Zip code 107-0052
Address Akasaka Intercity, 1-11-44, Akasaka, Minato-ku, Tokyo
TEL 03-4362-4504
Homepage URL
Email gpp_retro@mebix.co.jp

Sponsor
Institute Nippon Boehringer Ingelheim, Inc
Institute
Department

Funding Source
Organization Nippon Boehringer Ingelheim, Inc
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 Nagoya City University Graduate School of Medical Sciences and Nagoya City University Hospital Institutional Review Board
Address 1 Kawasumi, Mizuho-cho, Mizuho-ku, Nagoya, Japan.
Tel 052-851-5511
Email clinical_research@med.nagoya-cu.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
2021 Year 01 Month 04 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 Preinitiation
Date of protocol fixation
2020 Year 11 Month 16 Day
Date of IRB
Anticipated trial start date
2021 Year 02 Month 01 Day
Last follow-up date
2021 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective Chart Review

Management information
Registered date
2020 Year 12 Month 28 Day
Last modified on
2020 Year 12 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048927

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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