UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057238 |
|---|---|
| Receipt number | R000065395 |
| Scientific Title | Analysis of the Risk of Developing Autoimmune Diseases Associated with the Use of Biologic Agents Targeting Type 2 Immunity: An Observational Study Using Routinely Collected Health Data |
| Date of disclosure of the study information | 2025/03/07 |
| Last modified on | 2025/12/03 22:36:37 |
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Basic information
Public title
Analysis of the Risk of Developing Autoimmune Diseases Associated with the Use of Biologic Agents Targeting Type 2 Immunity: An Observational Study Using Routinely Collected Health Data
Acronym
Association Between Anti-Type 2 Immunity Agents and the Onset of Autoimmune Diseases
Scientific Title
Analysis of the Risk of Developing Autoimmune Diseases Associated with the Use of Biologic Agents Targeting Type 2 Immunity: An Observational Study Using Routinely Collected Health Data
Scientific Title:Acronym
Association Between Anti-Type 2 Immunity Agents and the Onset of Autoimmune Diseases
Region
| Japan |
Condition
Condition
Atopic dermatitis, Bronchial asthma, Chronic urticaria, Eosinophilic chronic rhinosinusitis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the risk of developing autoimmune diseases associated with the use of anti-type 2 immunity agents
Basic objectives2
Others
Basic objectives -Others
This study is an observational study using existing anonymized, routinely collected health data.
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The composite outcome of the following autoimmune diseases:
Rheumatoid arthritis, systemic erythematosus, Sjogren's syndrome, dermatomyositis/polymyositis, mixed connective tissue disease, systemic sclerosis, polymyalgia rheumatica, ANCA-associated vasculitis, large vessel vasculitis, polyarteritis nodosa, psoriasis
Key secondary outcomes
The components of the primary outcome
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
In this study, we will use the JMDC database. Patients diagnosed with atopic dermatitis (AD), bronchial asthma (BA), chronic urticaria (CU), or eosinophilic chronic rhinosinusitis (ECRS) after April 2018 were included. This cutoff date was chosen based on the most recent approval date among the exposure drugs (mepolizumab, benralizumab, dupilumab, and omalizumab). The definition for AD and BA required at least two diagnoses with an interval of 1-12 months, along with related medication, based on a previous validation study. For CU and ECRS, at least two recorded diagnoses with an interval of 1-12 months were required. The first diagnosis was defined as the index date (day 0). After that, patients were required to have continuous enrollment for >=365 days, no history of the exposure drugs, be aged >=18 years, and have at least one visit after day 0. For each outcome, patients with a pre-existing diagnosis of the relevant condition were excluded from the analysis.
Key exclusion criteria
Not applicable
Target sample size
1000000
Research contact person
Name of lead principal investigator
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inokuichi |
Organization
JMDC Inc.
Division name
Real World Evidence Division, Pharmaceutical Business Unit
Zip code
105-0012
Address
12th Floor, Sumitomo Shiba Daimon Building, 2-5-5 Shiba Daimon, Minato-ku, Tokyo 105-0012, Japan
TEL
03-5733-5010
shoichiro.inokuchi.nhy@jmdc.co.jp
Public contact
Name of contact person
| 1st name | Shoichiro |
| Middle name | |
| Last name | Inokuchi |
Organization
JMDC Inc.
Division name
Real World Evidence Division, Pharmaceutical Business Unit
Zip code
105-0012
Address
12th Floor, Sumitomo Shiba Daimon Building, 2-5-5 Shiba Daimon, Minato-ku, Tokyo 105-0012, Japan
TEL
03-5733-5010
Homepage URL
shoichiro.inokuchi.nhy@jmdc.co.jp
Sponsor or person
Institute
JMDC Inc.
Institute
Department
Personal name
Funding Source
Organization
JMDC Inc.
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
Not applicable
Address
Not applicable
Tel
NA
NA
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 | 03 | 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
Completed
Date of protocol fixation
| 2025 | Year | 02 | Month | 28 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 28 | Day |
Anticipated trial start date
| 2025 | Year | 02 | Month | 28 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This observational study will use the existing anonymized database.
Due to the use of an anonymized, pre-existing database, IRB approval was waived.
Management information
Registered date
| 2025 | Year | 03 | Month | 07 | Day |
Last modified on
| 2025 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065395
