UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055159 |
|---|---|
| Receipt number | R000063020 |
| Scientific Title | Evaluation of Disease Status of Psoriatic Arthritis Using 23Na-MRI |
| Date of disclosure of the study information | 2024/08/05 |
| Last modified on | 2025/02/03 09:05:10 |
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Basic information
Public title
Evaluation of Disease Status of Psoriatic Arthritis Using 23Na-MRI
Acronym
Evaluation of Disease Status of Psoriatic Arthritis Using 23Na-MRI
Scientific Title
Evaluation of Disease Status of Psoriatic Arthritis Using 23Na-MRI
Scientific Title:Acronym
Evaluation of Disease Status of Psoriatic Arthritis Using 23Na-MRI
Region
| Japan |
Condition
Condition
Psoriatic Arthritis
Classification by specialty
| Clinical immunology | Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
There is currently no established biomarker for evaluating the disease status of psoriatic arthritis. Imaging studies typically include X-rays, musculoskeletal ultrasound, and MRI. In this study, we will use 23Na-MRI to evaluate the pathogenesis of psoriatic arthritis and to examine the usefulness associated with 23Na-MRI.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Accumulation of sodium in skin evaluated by 23Na-MRI
Key secondary outcomes
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. Adult patients who meet CASPAR criteria
2. Patients with arthralgia
3. Patients with eGFR 60ml/min/1.73m2 or more
Key exclusion criteria
1. Blood pressure >140/90mmHg at screening
2. HbA1c>6.5% at screening
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
kaoru_t@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Stem Cell and Immune Regulation
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2630
Homepage URL
kaoru_t@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Graduate School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yokohama City University Hospital
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-370-7627
rinri@yokohama-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
| 2024 | Year | 08 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 25 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 22 | Day |
Anticipated trial start date
| 2024 | Year | 08 | Month | 05 | 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 this study, 23Na-MRI of the lower leg will be performed to measure blood and urine electrolytes and osmotic pressure items and to analyze the relationship between skin Na accumulation and disease activity and electrolytes.
Management information
Registered date
| 2024 | Year | 08 | Month | 05 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063020
