UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059519 |
|---|---|
| Receipt number | R000068079 |
| Scientific Title | Special Drug Use Result Survey of IMAAVY in patients with generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids) |
| Date of disclosure of the study information | 2025/10/29 |
| Last modified on | 2025/10/23 15:39:57 |
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Basic information
Public title
Special Drug Use Result Survey of IMAAVY in patients with generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids)
Acronym
IMA1L
Scientific Title
Special Drug Use Result Survey of IMAAVY in patients with generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids)
Scientific Title:Acronym
IMA1L
Region
| Japan |
Condition
Condition
generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids)
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This survey is to be conducted in patients who receive IMAAVY 1200 mg for I.V. Infusion and IMAAVY 300 mg for I.V. Infusion for the first time (Hereinafter referred to as this drug) for generalized myasthenia gravis (limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids) to evaluate the occurrence status of infection at the time of administration (including serious cases) and to confirm and investigate the relationship between the change in total IgG concentration and the occurrence and seriousness of infection.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1)Occurrence of safety specifications (infections)
2)Relationship between changes in total IgG levels and the occurrence and seriousness of infections
3)Factors that may affect the onset of infection (e.g., onset status by patient background)
4)Incidence of adverse drug reactions
Key secondary outcomes
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 are receiving their first administration of this drug for generalized myasthenia gravis(limited to patients who do not sufficiently respond to steroids or immunosuppressants other than steroids) .
Key exclusion criteria
Patients with prior use of IMAAVY
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Koyama |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Delivery Unit
Zip code
101-0065
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL
090-2037-9359
tkoyama4@ITS.JNJ.com
Public contact
Name of contact person
| 1st name | Asami |
| Middle name | |
| Last name | Otsuka |
Organization
Janssen Pharmaceutical K.K.
Division name
Medical Affairs Delivery Unit
Zip code
101-0065
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
TEL
070-2668-6638
Homepage URL
aotsuka@its.jnj.com
Sponsor or person
Institute
Janssen Pharmaceutical K.K.
Institute
Department
Personal name
Funding Source
Organization
Janssen Pharmaceutical 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
Janssen Pharmaceutical K.K.
Address
5-2, Nishi-Kanda 3-chome, Chiyoda-ku, Tokyo
Tel
070-2668-6638
aotsuka@its.jnj.com
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 | 10 | Month | 29 | 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
| 2025 | Year | 09 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 30 | Day |
Last follow-up date
| 2031 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Special Drug Use Result Survey
Management information
Registered date
| 2025 | Year | 10 | Month | 23 | Day |
Last modified on
| 2025 | Year | 10 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068079
