UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045677 |
|---|---|
| Receipt number | R000052140 |
| Scientific Title | A survey for Actual Usage of Tocilizumab in Adult Still's Disease Using a Japanese Healthcare Database |
| Date of disclosure of the study information | 2021/10/07 |
| Last modified on | 2023/09/04 18:59:52 |
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Basic information
Public title
A survey for Actual Usage of Tocilizumab in Adult Still's Disease Using a Japanese Healthcare Database
Acronym
A survey for Actual Usage of Tocilizumab in Adult Still's Disease Using a Japanese Healthcare Database
Scientific Title
A survey for Actual Usage of Tocilizumab in Adult Still's Disease Using a Japanese Healthcare Database
Scientific Title:Acronym
A survey for Actual Usage of Tocilizumab in Adult Still's Disease Using a Japanese Healthcare Database
Region
| Japan |
Condition
Condition
Adult Still's Disease
Classification by specialty
| Clinical immunology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate treatment patterns and change in corticosteroid dosage concomitant with tocilizumab on adult Still's disease in real world setting
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of less than 5mg/day of corticosteroid dosage after 1 year tocilizumab administration
Key secondary outcomes
Analysis of treatment patterns, etc.
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cohort 1
Patients 16 years and older with having diagnostic codes (ICD-10 codes; M061(Adult Still7s disease: ASD) or M082(systemic Juvenile idiopathic arthritis: sJIA)) in 2017-2021.
Cohort 2
Patients 16 years and older with having diagnostic codes (ICD-10 codes; M061(ASD) or M082(sJIA)) and treated with tocilizumab in 2019-2021.
Key exclusion criteria
Cohort 2
Patients treated with tocilizumab in the past 6 months.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ouchi |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
Medical Affairs Div.
Zip code
1038324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku Tokyo
TEL
03-3273-0866
ohuchikor@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Kondo |
Organization
CHUGAI PHARMACEUTICAL CO.,LTD.
Division name
Medical Science Dept.
Zip code
1038324
Address
1-1 Nihonbashi-Muromachi 2-Chome, Chuo-Ku Tokyo
TEL
09052181244
Homepage URL
kondosts@chugai-pharm.co.jp
Sponsor or person
Institute
CHUGAI PHARMACEUTICAL CO.,LTD.
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
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
| 2021 | Year | 10 | Month | 07 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
http://doi.org/10.1111/1756-185X.14848
Number of participants that the trial has enrolled
193
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Paper resubmission in progress.
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
| 2021 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 01 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 06 | Month | 05 | Day |
Other
Other related information
[Organization for analysis]
Intage Healthcare Inc.
[Organization providing data]
Medical Data Vision Co.,Ltd.
[Medical Expert]
Yuko Kaneko, Division of Rheumatology, Department of Internal Medicine, Keio University School of Medicine
[Study advisor]
Yoshiya Tanaka, the First Department of Internal Medicine, School of Medicine, University of Occupational and Environmental Health
Hideto Kameda, Division of Rheumatology, Department of Internal Medicine, Toho University
Kei Ikeda, Department of Allergy and Clinical Immunology, Chiba University Hospital
Management information
Registered date
| 2021 | Year | 10 | Month | 06 | Day |
Last modified on
| 2023 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052140
