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 | 2025/04/09 13:13:10 |
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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 and/or intolerant to previous therapy (New users are defined as participants to commence treatment on baseline visit date. Existing users are defined as those who commenced treatment prior to the baseline visit since November 1st, 2019.)
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, anti-inflammatory or analgesic systemic therapy such as oral corticosteroid, DMARDs, non-steroidal anti-inflammatory drugs, opioids, PDE4 inhibitor, or biologics for any other indication (e.g., psoriasis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, asthma)
2.have 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.are participating in an investigational study
4.are participating in another observational study for guselkumab (including a post-marketing surveillance study)
5.are unable to understand or sign a participation agreement/informed consent form
6.if the only treatment they have received for PPP has been antibiotics when the decision was made.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Pauline |
| Middle name | |
| Last name | Ng |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Division
Zip code
101-0065
Address
3-5-2 Nishi-Kanda, Chiyoda-ku, Tokyo
TEL
03-4411-7700
png16@its.jnj.com
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Sugiura |
Organization
Janssen Pharmaceutical 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
ysugiura@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical 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
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
276
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 11 | Month | 21 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 29 | 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 September 2023, 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
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047894
