UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024292 |
|---|---|
| Receipt number | R000026563 |
| Scientific Title | Identification of risk factor for spondyloarthropathy in patients diagnosed with psoriasis |
| Date of disclosure of the study information | 2016/10/05 |
| Last modified on | 2020/04/11 08:17:30 |
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Basic information
Public title
Identification of risk factor for spondyloarthropathy in patients diagnosed with psoriasis
Acronym
Island study
Scientific Title
Identification of risk factor for spondyloarthropathy in patients diagnosed with psoriasis
Scientific Title:Acronym
Island study
Region
| Japan |
Condition
Condition
psoriatic arthritis
Classification by specialty
| Clinical immunology | Dermatology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify the risk factor for spondyloarthritis in patients with psoriasis
Basic objectives2
Others
Basic objectives -Others
Observational study of psoriatic arthritis
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
identification of risk factor for spondyloarthropathy in the patients of psoriasis
Key secondary outcomes
identification of poor prognostic factor for psoriatic arthritis
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
adult outpatients with psoriasis or psoriatic arthritis
Key exclusion criteria
1) Outpatients who are not able to visit regulary
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Okano |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-Ku, Osaka City
TEL
0666453851
ma1sa3ru@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Okano |
Organization
Osaka City University Graduate School of Medine
Division name
Department of Orthopaedic Surgery
Zip code
545-8585
Address
1-4-3 Asahi-machi, Abeno-Ku, Osaka City
TEL
0666453851
Homepage URL
ma1sa3ru@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Orthopaedic Surgery,
Osaka City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
N/A
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
Osaka City University Hospital Certified Review Board
Address
1-4-3 Asahi-machi, Abeno-Ku, Osaka City
Tel
06-6645-6125
ethics@med.osaka-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
| 2016 | 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
Enrolling by invitation
Date of protocol fixation
| 2015 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2015 | Year | 06 | Month | 02 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
in order to analyze the risk factors for spondyloarthritis in the outpatients with psoriasis, patients baseline information, clinical findings, radiological findings, ultrasonographic findings will be obtained.
Management information
Registered date
| 2016 | Year | 10 | Month | 04 | Day |
Last modified on
| 2020 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026563
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
