UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051155 |
|---|---|
| Receipt number | R000058342 |
| Scientific Title | Treatment of Myasthenia Gravis (MG) Focusing on Corticosteroid Dose: An Insurance Claims Database Study in Japan |
| Date of disclosure of the study information | 2023/05/25 |
| Last modified on | 2025/05/26 22:41:01 |
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Basic information
Public title
Treatment of Myasthenia Gravis (MG) Focusing on Corticosteroid Dose: An Insurance Claims Database Study in Japan
Acronym
Treatment pattern on MG
Scientific Title
Treatment of Myasthenia Gravis (MG) Focusing on Corticosteroid Dose: An Insurance Claims Database Study in Japan
Scientific Title:Acronym
Treatment pattern on MG
Region
| Japan |
Condition
Condition
Myasthenia Gravis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In clinical practices, a treatment pattern of myasthenia gravis (MG) and long-term oral corticosteroid (OCS) on MG patients have been not verified sufficiently. Especially, a verification of factors / efficacies on an early achievement of treatment goal has led to raise am awareness. Thus, the purpose of this study is to analyze a treatment pattern on MG patients (e.g., dose of OCS), an achievement of < 5 mg/day of OCS, and a prognosis, using an insurance claims database.
Basic objectives2
Others
Basic objectives -Others
Main outcomes are as described below.
- Achievement of < 5mg/day oral corticosteroid
- Time to achieve < 5mg/day oral corticosteroid
- Steroid-related complications, including diabetes mellitus, osteoporosis
- To describe MG treatment patterns in patient subgroups with and without EFT categorized by age groups
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Main outcomes are as described below.
- Achievement of < 5mg/day oral corticosteroid
- Time to achieve < 5mg/day oral corticosteroid
- To describe MG treatment patterns in patient subgroups with and without EFT categorized by age groups
Key secondary outcomes
Secondary outcomes are as described below.
- Steroid-related complications, including diabetes mellitus, osteoporosis)
- Total number of medical procedures performed after the index date
- Percentage change in annual total MG-related costs before and after the index date
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
| 16 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria will be as described below.
- Having a confirmed diagnosis of MG (ICD-10 code: G70.0) recorded during the selection period
- Having at least 180 days baseline period
- Having at least one claim with an immunotherapy recorded at or within 90 days after the first MG diagnosis
- Being aged 16 years or older at the index date
Key exclusion criteria
Exclusion criteria will be as described below.
- Having any immunotherapy for longer than 90 days during the baseline period until 90 days before the index date
- Having a claim with MG treatment recorded any time until 90 days before the index date
Target sample size
2000
Research contact person
Name of lead principal investigator
| 1st name | Yohei |
| Middle name | |
| Last name | Ohashi |
Organization
UCB Japan Co.,Ltd.
Division name
Medical Affairs Rare Disease, Medical Affairs Japan
Zip code
160-0023
Address
Shinjuku Grand Tower, 8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6864-7676
yohei.ohashi@ucb.com
Public contact
Name of contact person
| 1st name | Kentaro |
| Middle name | |
| Last name | Taki |
Organization
UCB Japan Co.,Ltd.
Division name
Medical Affairs Rare Disease, Medical Affairs Japan
Zip code
160-0023
Address
Shinjuku Grand Tower, 8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-6864-7578
Homepage URL
kentaro.taki@ucb.com
Sponsor or person
Institute
UCB Japan Co.,Ltd.
Institute
Department
Personal name
Funding Source
Organization
UCB Japan Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
The collaborative organization will be as described below.
- Department of Neurology, Toho University Ohashi Medical Center
- Department of Neurology, Graduate School of Medicine, Chiba University
- Department of Neurology, Kindai University, Faculty of Medicine
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Institute of Healthcare Data Science, Institutional Review Board
Address
12th Floor, Sumitomo Shiba Daimon Building, 2-5-5 Shiba Daimon, Minato-ku, Tokyo 105-0012
Tel
03-5733-5010
rihds@jmdc.co.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
| 2023 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
https://rihds.org/docs/20240222_rinri.pdf
Publication of results
Partially published
Result
URL related to results and publications
http://jsn35.jp/images/program.pdf
Number of participants that the trial has enrolled
2000
Results
1. Achievement rates of OCS below 5mg/day were higher after 2015 than before 2014.
2. Lower doses of OCS (below 5mg/day) were more frequently observed after 2015 than before 2014 in the first 12 weeks.
3. Steroid-related complications were more frequent among patients who did not achieve below 5mg/day OCS, such as diabetes in JMDC and osteoporotic fracture in LSEHS.
4. Use of OCS and EFT in Japan was less frequent and at lower doses in LSEHS than in NHI.
Results date posted
| 2023 | Year | 11 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
This study has a retrospective cohort design. A cohort of MG patients newly treated with immunotherapy was derived based on secondary use of three claims databases: JMDC-payer database (JMDC), National Health Insurance (NHI) and Late-Stage Elderly Health Insurance (LSEHS) databases.
The index date was defined as the date of the first dispensing of immunotherapy after the MG diagnosis. The baseline period was defined as the 180-day period before the index date. The follow-up period was defined as the period starting from the index date until the end of the study period (31 December 2021), end of enrolment or death, whichever came first.
Participant flow
This study has a retrospective cohort design. A cohort of MG patients newly treated with immunotherapy was derived based on secondary use of three claims databases: JMDC-payer database (JMDC), National Health Insurance (NHI) and Late-Stage Elderly Health Insurance (LSEHS) databases.
Adverse events
Nothing
Outcome measures
Main outcomes are as described below.
- Achievement of < 5mg/day oral corticosteroid
- Time to achieve < 5mg/day oral corticosteroid
- To describe MG treatment patterns in patient subgroups with and without EFT categorized by age groups
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2023 | Year | 04 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 20 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing to report.
Management information
Registered date
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2025 | Year | 05 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058342
