UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040742 |
|---|---|
| Receipt number | R000046516 |
| Scientific Title | Cost-effectiveness analysis of bDMARDs and tsDMARDs in patients with rheumatoid arthritis : Conventional model simulation and alternative approaches based on real world data |
| Date of disclosure of the study information | 2020/06/22 |
| Last modified on | 2022/06/06 17:47:12 |
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Basic information
Public title
Cost-effectiveness analysis of bDMARDs and tsDMARDs in patients with rheumatoid arthritis
Acronym
Cost-effectiveness analysis of bDMARDs and tsDMARDs in patients with rheumatoid arthritis
Scientific Title
Cost-effectiveness analysis of bDMARDs and tsDMARDs in patients with rheumatoid arthritis : Conventional model simulation and alternative approaches based on real world data
Scientific Title:Acronym
Cost-effectiveness analysis of bDMARDs and tsDMARDs in patients with rheumatoid arthritis : Conventional model simulation and alternative approaches based on real world data
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Presenting the current cost-effectiveness of bDMARDs / tsDMARDs in Japanese patients with rheumatoid arthritis
Basic objectives2
Others
Basic objectives -Others
cost-effectiveness
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Incremental cost-effectiveness ratio (ICER) after starting treatment with each bDMARDs / tsDMARDs or MTX
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
-
Key exclusion criteria
-
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kaori |
| Middle name | |
| Last name | Ouchi |
Organization
Chugai Pharmaceutical Co.,Ltd.
Division name
Medical Science Dept.
Zip code
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome,Chuo-Ku Tokyo
TEL
03-3273-0866
kondosts@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
103-8324
Address
1-1 Nihonbashi-Muromachi 2-Chome,Chuo-Ku Tokyo
TEL
03-3273-0866
Homepage URL
kondosts@chugai-pharm.co.jp
Sponsor or person
Institute
Chugai Pharmaceutical Co.,Ltd.
Medical Science Dept.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co.,Ltd.
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
| 2020 | Year | 06 | Month | 22 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/35445720/
Number of participants that the trial has enrolled
3262
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 04 | Month | 21 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
-
Management information
Registered date
| 2020 | Year | 06 | Month | 12 | Day |
Last modified on
| 2022 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046516
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
