UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056401 |
|---|---|
| Receipt number | R000064438 |
| Scientific Title | Clinical Study Concerning Efgartigimod for the Treatment of CIDP Patients Enrolled in Neuroimmunological Disorders Registry |
| Date of disclosure of the study information | 2025/04/01 |
| Last modified on | 2024/12/09 12:59:41 |
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Basic information
Public title
Clinical Study Concerning Efgartigimod for the Treatment of CIDP Patients Enrolled in Neuroimmunological Disorders Registry
Acronym
Clinical Study Concerning Efgartigimod for the Treatment of CIDP Patients
Scientific Title
Clinical Study Concerning Efgartigimod for the Treatment of CIDP Patients Enrolled in Neuroimmunological Disorders Registry
Scientific Title:Acronym
Clinical Study Concerning Efgartigimod for the Treatment of CIDP Patients
Region
| Japan |
Condition
Condition
Neuroimmune Disease
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study collects and analyzes clinical data from CIDP patients before and after starting Efgartigimod, aiming to clarify its long-term efficacy and safety in real-world settings.
Basic objectives2
Others
Basic objectives -Others
We will establish a system to enable efficient recruitment of patients for clinical trials. This will contribute to the development and establishment of new treatment methods for neuroimmune diseases.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
The course of clinical endpoints mainly used for each neuroimmune disease.
Key secondary outcomes
1. EQ-5D-5L
2. Treatment response
3. Adverse event
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
1) CIDP patients* registered in the Neuroimmunological Disease Registry (as described in the study protocol [RADDAR-J[79]]) who are scheduled to begin Efgartigimod treatment
*patients diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) based on the 2024 Clinical Practice Guidelines for CIDP and Multifocal Motor Neuropathy (MMN)
2) Patients who have provided written informed consent to participate in this study
Key exclusion criteria
Patients deemed inappropriate for inclusion by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoshi |
| Middle name | |
| Last name | Kuwabara |
Organization
Graduate School of Medicine and School of Medicine, Chiba University
Division name
Department of Neurology, Professor
Zip code
2608677
Address
1-8-1 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL
0432262126
kuwabara-s@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Shigeki |
| Middle name | |
| Last name | Omori |
Organization
General Incorporated Association kizuna
Division name
Secretariat
Zip code
2600856
Address
1-8-15 Inohana, Chuo-ku, Chiba City, Chiba Prefecture
TEL
0432397670
Homepage URL
https://www.janima.org
oomori-s@kizunaai.org
Sponsor or person
Institute
The Japanese Society for Neuroimmunology
Institute
Department
Personal name
Funding Source
Organization
General Incorporated Association kizuna
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-u.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
| 2025 | Year | 04 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Although the research period is permanent, ethical review approval and research permission will be obtained every five years.
Management information
Registered date
| 2024 | Year | 12 | Month | 09 | Day |
Last modified on
| 2024 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064438
