UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051151 |
|---|---|
| Receipt number | R000058333 |
| Scientific Title | Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database |
| Date of disclosure of the study information | 2023/06/01 |
| Last modified on | 2024/03/11 17:50:54 |
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Basic information
Public title
Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database
Acronym
Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database
Scientific Title
Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database
Scientific Title:Acronym
Incidence and risk factors of serious infection in neuromyelitis optica spectrum disorders (NMOSD) patients: a retrospective cohort study using Medical Data Vision (MDV) database
Region
| Japan |
Condition
Condition
Neuromyelitis optica spectrum disorders (NMOSD)
Classification by specialty
| Neurology | Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Primary objective: to estimate the incidence of serious infections among them
Secondary objective: to determine the risk factors for serious infections among patients with NMOSD in Japan
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence rate, proportion, frequency, cumulative incidence, cumulative mean count of serious infections
Key secondary outcomes
Hazard ratios of potential risk factors for serious infections
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
The patients who have the earliest NMOSD diagnosis (ICD-10 code G36.0, without suspicious flag) recorded in a certain hospital during the patient selection period (2016-01-01 to 2022-08-31). The index date is the first diagnosis.
Key exclusion criteria
The patients who have any record of prescription for the following drugs for the treatment of multiple sclerosis (MS) at any time point:
- Interferon beta-1a,
- Interferon beta-1b,
- Ofatumumab,
- Natalizumab,
- Glatiramer acetate,
- Dimethyl fumarate,
- Siponimod fumarate,
- Fingolimod hydrochloride.
Target sample size
4000
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Matsuda |
Organization
Chugai Pharmaceutical Co., Ltd
Division name
Risk Communication Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
matsudasni@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Matsuda |
Organization
Chugai Pharmaceutical Co., Ltd
Division name
Risk Communication Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-muromachi 2-chome, Chuo-ku Tokyo, Japan
TEL
03-3281-6611
Homepage URL
matsudasni@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Non-Profit Organization MINS Institutional Review Board
Address
1-15-14, Dogenzaka, Shibuya, Tokyo, Japan
Tel
03-6416-1868
npo-mins@j-irb.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
| 2023 | Year | 06 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 01 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
[Organization for analysis]
IQVIA Solutions Japan K.K.
[Organization providing data]
Medical Data Vision Co., Ltd.
Management information
Registered date
| 2023 | Year | 05 | Month | 24 | Day |
Last modified on
| 2024 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058333
