UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060279 |
|---|---|
| Receipt number | R000068864 |
| Scientific Title | A multicenter retrospective observational study of patients with generalized myasthenia gravis treated with efgartigimod |
| Date of disclosure of the study information | 2026/01/07 |
| Last modified on | 2026/01/07 11:11:10 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A multicenter retrospective observational study of patients with generalized myasthenia gravis treated with efgartigimod
Acronym
Retrospective observational study of patients with gMG treated with efgartigimod
Scientific Title
A multicenter retrospective observational study of patients with generalized myasthenia gravis treated with efgartigimod
Scientific Title:Acronym
Retrospective observational study of patients with gMG treated with efgartigimod
Region
| Japan |
Condition
Condition
generalized myasthenia gravis
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe the medical history of patients with generalized myasthenia gravis (gMG) treated with efgartigimod, including the treatment history of gMG, symptoms of gMG, and adverse events before and after efgartigimod treatment. This study will use a post-marketing surveillance study data.
Basic objectives2
Others
Basic objectives -Others
Clarify the medical history including treatment history, symptoms, and adverse events before and after efgartigimod therapy in gMG.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To describe the treatment patterns and MG symptoms before and after administration of efgartigimod.
Key secondary outcomes
1)To describe the frequency of MG symptoms and changes in MG treatment with efgartigimod and pretreatment
2)To describe the correlation between incidence of adverse events before and after administration of efgartigimod
3)To describe changes in treatment patterns, MG symptoms, and MG treatment frequency in seropositive and double-seronegative cases treated with efgartigimod
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)Patients enrolled in the specific post-marketing surveillance (PMS) study for efgartigimod intravenous (IV) formulation or subcutaneous (SC) formulation for generalized myasthenia gravis (gMG)
2)Patients who had no prior treatment with efgartigimod before enrollment in PMS
Key exclusion criteria
Patients who had prior treatment with efgartigimod before enrollment in PMS
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Hirofumi |
| Middle name | n/a |
| Last name | Teranishi |
Organization
argenx Japan K.K.
Division name
Medical Affairs Department
Zip code
107-0052
Address
2-5-8, Akasaka, Minato-ku, Tokyo, Japan
TEL
080-1010-9922
hteranishi@argenx.com
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | n/a |
| Last name | Matsuura |
Organization
Ark Medical Solutions Inc.
Division name
Clinical Research
Zip code
1700013
Address
13F Hareza Tower,1-18-1 Higashi-Ikebukuro Toshima-ku, Tokyo, Japan
TEL
03-5979-1001
Homepage URL
h.matsuura@arkms.com
Sponsor or person
Institute
argenx Japan K.K.
Institute
Department
Personal name
Hirofumi Teranishi
Funding Source
Organization
argenx Japan 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
Review Board of Human Rights and Ethics for Clinical Studies(HURECS)
Address
2-2-1 Kyobashi, Chuo-ku, Tokyo, Japan
Tel
03-6665-0572
soudan@hurecs.org
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
公益社団法人花巻共立会 総合花巻病院（岩手県）、千葉大学医学部附属病院（千葉県）、香川大学医学部附属病院（香川県）、愛媛大学医学部附属病院（愛媛県）、岡山医療センター（岡山県）、大阪市立総合医療センター（大阪府）、市立函館病院（北海道）、東邦大学医療センター大橋病院（東京都）、東京都立病院機構 東京都立神経病院（東京都）、札幌医科大学附属病院（北海道）、青森県立中央病院（青森県）、奈良県立医科大学（奈良県）、慶應義塾大学病院（東京都）、獨協医科大学埼玉医療センター（埼玉県）、熊本大学病院（熊本県）、社会医療法人鴻仁会 岡山中央病院（岡山県）、京都府立医科大学附属病院（京都府）、産業医科大学病院（福岡県）、佐賀大学医学部附属病院（佐賀県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 07 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To describe the medical history of patients with generalized myasthenia gravis (gMG) treated with efgartigimod, including the treatment history of gMG, symptoms of gMG, and adverse events before and after efgartigimod treatment. This study will use a post-marketing surveillance study data.
Management information
Registered date
| 2026 | Year | 01 | Month | 07 | Day |
Last modified on
| 2026 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068864
