UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046505 |
|---|---|
| Receipt number | R000052986 |
| Scientific Title | Analysis of clinical situation and treatment patterns in CIDP patients based on claims data in Japan |
| Date of disclosure of the study information | 2021/12/29 |
| Last modified on | 2024/10/08 18:55:25 |
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Basic information
Public title
Analysis of clinical situation and treatment patterns in CIDP patients based on claims data in Japan
Acronym
Analysis of clinical situation and treatment patterns in CIDP patients based on claims data in Japan
Scientific Title
Analysis of clinical situation and treatment patterns in CIDP patients based on claims data in Japan
Scientific Title:Acronym
Analysis of clinical situation and treatment patterns in CIDP patients based on claims data in Japan
Region
| Japan |
Condition
Condition
Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we intend to uncover the real-world clinical practice in Japan on diagnostic tests and treatments provided to CIDP patients as a primary objective. We also intend to look into the safety of long-term steroids and IVIg use in CIDP as an exploratory objective.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The percentage of patients examined with each diagnostic test leading up to the CIDP diagnosis.
The percentage of CIDP patients treated with each treatment (IVIg, Steroids, Plasma exchange, Immunosuppressants).
Key secondary outcomes
Treatment patterns of CIDP patients in clinical practice in Japan.
Diseases that need to be differentiated from CIDP and actual conditions of CIDP diagnosis.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who meet the following criteria are the subjects of this study.
Patients who meet the following criteria in the MDV database between April 13, 2008 and August 31, 2018.
Patients with ICD-10 code: G618 and classified as CIDP during the data period (excluding multifocal motor neuropathy (MMN)).
Key exclusion criteria
N/A
Target sample size
4500
Research contact person
Name of lead principal investigator
| 1st name | Motoi |
| Middle name | |
| Last name | Kuwahara |
Organization
Kindai University Faculty of Medicine
Division name
Department of Neurology
Zip code
589-8511
Address
377-2 Ohno-higashi, Osaka-sayama, Osaka, Japan
TEL
072-366-0221
kuwahara@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Er-Win |
| Middle name | |
| Last name | Hew |
Organization
CSL Behring K.K.
Division name
Medical Affairs
Zip code
107-0061
Address
1-2-3 Kitaaoyama, Minato-Ku, Tokyo, Japan
TEL
03-4213-0260
Homepage URL
JPN.Medical_Affairs@cslbehring.com
Sponsor or person
Institute
CSL Behring K.K.
Institute
Department
Personal name
Funding Source
Organization
CSL Behring K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kindai University medical department ethic screening committee
Address
377-2 Ohnohigashi, Osakasayama, Osaka Japan
Tel
072-366-0221
zizen@med.kindai.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
| 2021 | Year | 12 | Month | 29 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/full/10.1111/cen3.12813
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/full/10.1111/cen3.12813
Number of participants that the trial has enrolled
4564
Results
Of the 4564 patients with a diagnosis code for CIDP, 1658 patients were confirmed as newly assigned with the diagnosis code during the study period. Diagnostic tests performed before assignment of the diagnosis code for CIDP included nerve conduction studies in 48.1%, magnetic resonance imaging in 40.5%, and cerebrospinal fluid tests in 38.4%. Initial treatments performed after the assignment of the new diagnosis code for CIDP were intravenous immunoglobulin in 54.3% and corticosteroids in 45.4%.
Results date posted
| 2024 | Year | 10 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 09 | Month | 18 | Day |
Baseline Characteristics
Total for analysis 4654 patients (Whole CIDP-Dx group): 56.9% male, mean age 60.0 years
Newly diagnosed CIDP 1658 patients (Newly CIDP-Dx group): 56.2% male, mean age 61.0 years
Participant flow
A total of 4564 patients with ICD-10 code 'G618' classified as CIDP in the MDV database between April 13, 2008 and August 31, 2018 were included in the analysis (Whole CIDP-Dx group). Of these, 1658 patients were newly diagnosed with CIDP (Newly CIDP-Dx group).
Adverse events
NA
Outcome measures
Patient demographics, the percentage of diagnostic tests performed up to the assigned diagnosis code for CIDP, diseases that need to be differentiated from CIDP, the percentage of patients treated with each treatment after diagnosis of CIDP and treatment patterns of CIDP.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2021 | Year | 09 | Month | 27 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 22 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 27 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 27 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study uses the MDV database. The data is anonymized and no identifiable personal information is included in the database.
Management information
Registered date
| 2021 | Year | 12 | Month | 28 | Day |
Last modified on
| 2024 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052986
