UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042010
Receipt number 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 11:19:38

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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 or person

Institute

Janssen Pharma K.K.

Institute

Department

Personal name



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

Value
https://center6.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