UMIN-CTR Clinical Trial

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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