UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051032 |
|---|---|
| Receipt number | R000058183 |
| Scientific Title | Prevalence, comorbidities, and treatment patterns of patients with chronic spontaneous urticaria in Japan |
| Date of disclosure of the study information | 2023/05/15 |
| Last modified on | 2024/12/16 11:52:25 |
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Basic information
Public title
Prevalence, comorbidities, and treatment patterns of patients with chronic spontaneous urticaria in Japan
Acronym
Claim database study of chronic spontaneous urticaria in Japan
Scientific Title
Prevalence, comorbidities, and treatment patterns of patients with chronic spontaneous urticaria in Japan
Scientific Title:Acronym
Claim database study of chronic spontaneous urticaria in Japan
Region
| Japan |
Condition
Condition
chronic spontaneous urticaria
Classification by specialty
| Dermatology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate the current prevalence and incidence of CSU
To describe comorbidities, Healthcare resource utilization and current treatment for CSU
Basic objectives2
Others
Basic objectives -Others
Prevalence
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Annual prevalence of CSU is calculated by age and gender
Key secondary outcomes
Annual incidence rate of CSU is calculated by age and gender
Comorbidities, HCRU, and current treatment for CSU
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
| Not applicable |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The study population consists of the patients diagnosed with urticaria in the JMDC Claims Database, in 2015 to 2021 for this study
Key exclusion criteria
Not applicable
Target sample size
50000
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Arima |
Organization
Sanofi K.K.
Division name
Dermatology Medical Immunology Medical Specialty Care
Zip code
163-1488
Address
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-4575
Sanofi_Medical@sanofi.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | KISHI |
Organization
Sanofi K.K.
Division name
Dermatology Medical, Immunology Medical, Specialty Care
Zip code
163-1488
Address
Tokyo Opera City Tower, 3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6301-4575
Homepage URL
Sanofi_Medical@sanofi.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoyukai RiverSide Clinic
Address
2-1 west, 7 South, Chuo-ku, Sapporo, Hokkaido
Tel
011-521-2321
rinrishinsar@riversideclinic.or.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
該当なし/not applicable
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 15 | Day |
Related information
URL releasing protocol
N/A (not available)
Publication of results
Partially published
Result
URL related to results and publications
https://doi.org/10.14924/dermatol.134.1504
Number of participants that the trial has enrolled
76710
Results
Between 2016 and 2021, the prevalence of CSU tended to increase, from 1.2% to 1.6%; however, the new incidence remained constant, at 0.7 to 0.8%.
Comorbid allergic disease was observed in 96.2% in patients aged </=11 years, and 70.1% in >/=12 years. Allergic rhinitis and conjunctivitis were frequent in the overall population, while asthma and atopic dermatitis were frequent in </=11 years.
After antihistamines, the most commonly used drugs were topical steroids, which are not recommended in the guidelines.
Results date posted
| 2024 | Year | 06 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
0-11 years (n=19,665), 12-74 years (n=57,045)
Participant flow
Anonymised data from 2016-2021 were obtained from a Japanese health insurance claims database (JMDC Inc.). Patients with CSU were identified if they had idiopathic urticaria, other urticaria or unspecified urticaria based on ICD-10 codes and were prescribed antihistamines for >/=6 weeks over a 3-month period.
Adverse events
not collected
Outcome measures
CSU prevalence: 1.2% to 1.6% (between 2016 and 2021)
CSU incidence of new onset: 0.7 to 0.8% (between 2016 and 2021)
Comorbid allergic disease: 96.2% in patients aged </=11 years, and 70.1% in >/=12 years
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory Outcomes:
Prescription pattern
Time to 1st OCS/Cyclosporine/OMA treatment from index month
Pre- and post-treatment with OCS/Cyclosporine/OMA
Management information
Registered date
| 2023 | Year | 05 | Month | 10 | Day |
Last modified on
| 2024 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058183
