UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050079 |
|---|---|
| Receipt number | R000057029 |
| Scientific Title | Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database |
| Date of disclosure of the study information | 2023/01/19 |
| Last modified on | 2023/01/19 14:02:46 |
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Basic information
Public title
Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database
Acronym
Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database
Scientific Title
Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database
Scientific Title:Acronym
Development and validation of the risk prediction model for serious infections in rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Development of the risk prediction model for serious infections in Japanese rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database.
Basic objectives2
Others
Basic objectives -Others
Development of the risk prediction model for serious infections in Japanese rheumatoid arthritis (RA) patients treated with Tocilizumab using a medical information database.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The calibration capability of the model is visually represented by a calibration plot divided into 10 aliquots.
Area under the curve (AUC) is used as a measure of discrimination.
Sensitivity, specificity, and positive and negative predictive values at each 5% risk threshold are used as measures of accuracy.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The inclusion criteria are all of the following:
･Confirmed diagnosis of RA (ICD -10 Diagnosis Code M05/M06) can be identified during the baseline period (excluding diagnoses with the "Suspect" flag).
･Initial tocilizumab prescriptions are available during the patient selection period.
･Prescription of antirheumatic drugs during the baseline period.
Key exclusion criteria
Patients who meet any of the following criteria will be excluded from the study:
･Prescription of tocilizumab cannot be identified after index date.
･Patients with a history of treatment for malignant tumors during the baseline period (6 months immediately before the index date) and at the reference date
(defined as either of the following)
History of prescription of "injury/disease name of malignant tumor" and" antineoplastic drug" (However, methotrexate, rituximab, and tacrolimus are excluded from the list of "antineoplastic agents")
History of prescription of "radiotherapy"
･Patients who don't have a 4-month lookback period
･Patients with a confirmed disease name other than RA for which tocilizumab is indicated during the baseline period or index date
Indications listed for intravenous infusion: juvenile idiopathic arthritis, adult Still's disease, Castleman's disease, pneumonia caused by SARS-CoV-2, cytokine release syndrome
Indications listed for subcutaneous injection: Takayasu's arteritis, giant cell arteritis
Target sample size
6000
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
Chugai Pharmaceutical Co., Ltd.
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 | 01 | Month | 19 | 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
| 2022 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 03 | Month | 20 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 25 | 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 | 01 | Month | 19 | Day |
Last modified on
| 2023 | Year | 01 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057029
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