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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042010
Receipt No. R000047894
Scientific Title Registry of palmoplantar pustulosis (PPP) treatment patterns, disease burden and treatment outcomes in Japan
Date of disclosure of the study information 2020/10/05
Last modified on 2020/10/05

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Basic information
Public title Registry of palmoplantar pustulosis (PPP) treatment in Japan
Acronym PPP registry
Scientific Title Registry of palmoplantar pustulosis (PPP) treatment patterns, disease burden and treatment outcomes in Japan
Scientific Title:Acronym ProPuP
Region
Japan Asia(except Japan)

Condition
Condition palmoplantar pustulosis/pustulotic arthro-osteitis
Classification by specialty
Clinical immunology Dermatology Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The objectives of this descriptive study are to describe the treatment patterns, disease burden and treatment outcomes of palmoplantar pustulosis (PPP) and pustulotic arthro-osteitis (PAO) in Japan.
Basic objectives2 Others
Basic objectives -Others to describe the treatment patterns of patients receiving systemic treatment for PPP/pustulotic arthro-osteitis (PAO) in Japan.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Measures of Treatment Patterns
Information will be collected at baseline and during the observational period (if relevant) on the following PPP/PAO-related treatments
-Prior therapy history
-The immediately-prior PPP or PAO therapy to which the patient has had an inadequate response
-The index systemic PPP or PAO therapy being newly-commenced at the baseline visit
-Addition of another (concurrent) systemic PPP or PAO therapy
-Concurrent non-systemic therapies and/or other systemic therapies for PPP/PAO at baseline
-If switching from the index systemic PPP or PAO therapy, information on the 1st subsequent and 2nd subsequent systemic PPP or PAO therapies
Key secondary outcomes Measures of Disease Burden and Treatment Effectiveness
Information will be collected at baseline and during the observational period on the following variables relating to PPP disease burden and/or treatment effectiveness:
-Clinical disease status for PPP indicated by PGA, Pain-VAS and PPPASI
-Clinical disease status for PAO indicated by Pain-VAS, DAPSA and ASDAS
-PPP-associated comorbidities and treatments
-Quality of life as measured by EQ5D and DLQI
-Quality of life for PAO measured by HAQ-DI
-Work productivity as measured by the WPAI

Base
Study type Observational

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1.male or female aged at least 18 years of age,
2.must have a confirmed diagnosis of palmoplantar pustulosis (PPP) and/or pustulotic arthro-osteitis (PAO) by a certified dermatologist, rheumatologist and/or orthopedist in accordance with local clinical practice
3.Has previously been prescribed treatment for PPP/PAO
4.A decision has been made by the treating physician and the patient to commence treatment with a systemic PPP/PAO therapy, having been deemed to have an inadequate response to and/or intolerant previous therapy
5.must sign a participation agreement/informed consent form allowing data collection and source data verification in accordance with local requirements
Key exclusion criteria 1.are receiving, or have received within the past 3 months, systemic treatment with an oral corticosteroid, DMARDs, non-steroidal anti-inflammatory drugs, PDE4 inhibitor, or biologics for any other indication (eg. psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, asthma)
2.received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 3 months before the start of the study or the first data collection time point
3.participation in an investigational study
4.participation in another observational study for guselkumab (including a post-marketing surveillance study)
5.inability to understand or sign a participation agreement/informed consent form
6.if the only treatment they have received for PPP has been antibiotics
Target sample size 400

Research contact person
Name of lead principal investigator
1st name Shoichiro
Middle name
Last name Goto
Organization Janssen Pharma K.K.
Division name Medical Affairs Division
Zip code 101-0065
Address 3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo
TEL 03-4411-7700
Email SGOTO2@its.jnj.com

Public contact
Name of contact person
1st name Shinya
Middle name
Last name Nagasaki
Organization Janssen Pharma K.K.
Division name Medical Affairs Division
Zip code 101-0065
Address 3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo
TEL 03-4411-7700
Homepage URL
Email SNagasa5@ITS.JNJ.com

Sponsor
Institute Janssen Pharma K.K.
Institute
Department

Funding Source
Organization Janssen Pharma K.K.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Non-Profit Organization MINS Institutional Review Board
Address 2nd floor 1-15-14 Dogenzaka, Shibuya, Tokyo
Tel 03-6416-1868
Email npo-mins@j-irb.com

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
2020 Year 10 Month 05 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
2019 Year 11 Month 21 Day
Date of IRB
Anticipated trial start date
2020 Year 11 Month 30 Day
Last follow-up date
2025 Year 08 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This is a registry study. Patients recruited for this study will be chosen from the patients who visit the study site between November 2020 to August 2025, who satisfy the inclusion criteria and does not meet any of the exclusion criteria.

Management information
Registered date
2020 Year 10 Month 05 Day
Last modified on
2020 Year 10 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047894

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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