UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052793 |
|---|---|
| Receipt number | R000060181 |
| Scientific Title | An exploratory study to identify the factors related to recurrence of Generalized Pustular Psoriasis (GPP) flare in adult patients with GPP in Japan |
| Date of disclosure of the study information | 2023/11/22 |
| Last modified on | 2024/12/27 09:45:32 |
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Basic information
Public title
An exploratory study to identify the factors related to recurrence of Generalized Pustular Psoriasis (GPP) flare in adult patients with GPP in Japan
Acronym
An exploratory study to identify the factors related to recurrence of GPP flare
Scientific Title
An exploratory study to identify the factors related to recurrence of Generalized Pustular Psoriasis (GPP) flare in adult patients with GPP in Japan
Scientific Title:Acronym
An exploratory study to identify the factors related to recurrence of GPP flare
Region
| Japan |
Condition
Condition
Generalized Pustular Psoriasis (GPP)
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Are there any factors related to recurrence of Generalized Pustular Psoriasis (GPP) flares?
Basic objectives2
Others
Basic objectives -Others
This study will explore the factors related to recurrence of GPP flares, such as patient background, the severity of the baseline GPP flare, types of treatment, or infections, in patients with GPP.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Outcome: Recurrence of GPP flares in patients who experienced a GPP flare at baseline
Time Frame: From the date of onset of the baseline GPP flare to the date of recurrence of a GPP flare or to the end of the follow-up
Event: Recurrence of GPP flares confirmed by the Data Review Committee
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
-Patients who have been diagnosed with von Zumbusch type of GPP
-Patients who experienced a GPP flare at baseline confirmed by the Data Review Committee
-Patients whose data were properly obtained for this study in accordance with the local regulations
Key exclusion criteria
-Patients who have been diagnosed with paediatric GPP, impetigo herpetiformis, or other categories of GPP
-Patients who have been diagnosed with unknown disease categories of GPP
Target sample size
205
Research contact person
Name of lead principal investigator
| 1st name | Morihisa |
| Middle name | |
| Last name | Saitoh |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medical Affairs Group, Immunology Medicine Dept., Clinical Development Medical Affairs Oncology and Immunology, Medicine Div
Zip code
141-6017
Address
ThinkPark Tower, 2-1-1, Osaki, Shinagawa-ku, Tokyo
TEL
03-6417-2200
morihisa.saitoh@boehringer-ingelheim.com
Public contact
Name of contact person
| 1st name | Morihisa |
| Middle name | |
| Last name | Saitoh |
Organization
Nippon Boehringer Ingelheim Co., Ltd.
Division name
Medical Aff airs Group, Immunology Medicine Dept., Clinical Development Medical Affairs
Zip code
141-6017
Address
ThinkPark Tower, 2-1-1, Osaki, Shinagawa-ku, Tokyo
TEL
03-6417-2200
Homepage URL
morihisa.saitoh@boehringer-ingelheim.com
Sponsor or person
Institute
Nippon Boehringer Ingelheim Co., Ltd.
Institute
Department
Personal name
Morihisa Saitoh
Funding Source
Organization
Nippon Boehringer Ingelheim Co., Ltd.
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
Takahashi Clinic Ethics Committee
Address
Medicalhat 1F, 5-1-31, Iwaya-kitamachi, Nada-ku, Kobe-shi, Hyogo
Tel
078-882-6432
kishimoto.satoshi@neues.co.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
| 2023 | Year | 11 | Month | 22 | 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
150
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
Completed
Date of protocol fixation
| 2023 | Year | 11 | Month | 02 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2023 | Year | 11 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study will be conducted through secondary use of the existing data (UMIN ID: UMIN000042865; Study 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).
Management information
Registered date
| 2023 | Year | 11 | Month | 14 | Day |
Last modified on
| 2024 | Year | 12 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060181
