UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044713 |
|---|---|
| Receipt number | R000051068 |
| Scientific Title | Socio-economic impact of tocilizumab (TCZ), other bDMARD and tsDMARD treatment on Japanese Rheumatoid Arthritis patients using CorEvitas' RA Japan registry |
| Date of disclosure of the study information | 2021/07/01 |
| Last modified on | 2024/03/21 16:24:04 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Socio-economic impact of tocilizumab (TCZ), other bDMARD and tsDMARD treatment on Japanese Rheumatoid Arthritis patients
Acronym
Socio-economic impact of tocilizumab (TCZ), other bDMARD and tsDMARD treatment on Japanese Rheumatoid Arthritis patients
Scientific Title
Socio-economic impact of tocilizumab (TCZ), other bDMARD and tsDMARD treatment on Japanese Rheumatoid Arthritis patients using CorEvitas' RA Japan registry
Scientific Title:Acronym
Socio-economic impact of tocilizumab (TCZ), other bDMARD and tsDMARD treatment on Japanese Rheumatoid Arthritis patients using CorEvitas' RA Japan registry
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to evaluate the change of socio-economic impact of tocilizumab treatment from baseline to 12 months on Japanese rheumatoid arthritis patients.
Basic objectives2
Others
Basic objectives -Others
Cost-effective
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of Socio-economic impact of TCZ from 12month to baseline
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Key inclusion criteria of CorEvitas' RA Japan registry is following:
1) The subject must be diagnosed with rheumatoid arthritis according to the 1987 ACR or the ACR/EULAR 2010 Rheumatoid Arthritis Classification Criteria
2) The subject must be at least 18 years of age or older
3) The subject must be able and willing to provide written consent
4) The subject must be prescribed or switching to an eligible medication or the first time ever at the Enrollment Visit. History of or concomitant treatment with other eligible medications does not exclude a subject from enrollment.
This analysis will include only biologic-naive and JAK-naive initiators of the following drugs:
TCZ [tocilizumab]
TNFi [infliximab, etanercept, adalimumab, certolizumab pegol, golimumab]
CTLA4 [abatacept]
JAKi [tofacitinib, baricitinib]
Key exclusion criteria
-
Target sample size
500
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
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Nobuo |
| Middle name | |
| Last name | Nishijima |
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
Homepage URL
cma-clinicaltrial@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
Profit organization
Nationality of Funding Organization
Japan
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 | 07 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36629510/
Number of participants that the trial has enrolled
301
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
| 2021 | Year | 06 | Month | 02 | Day |
Date of IRB
| 2021 | Year | 06 | Month | 16 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This research will be conducted using the database of CorEvitas' RA Japan registry operated by CorEvitas, LLC.
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000024117
[Organization for analysis]
CorEvitas, LLC
1440 Main Street, Suite 310,
Waltham, Massachusetts 02451, U.S.A
[Academic Steering Committee of CorEvitas' RA Japan registry]
Hisashi Yamanaka (Sanno Medical Center)
Yoshiya Tanaka (University of Occupational and Environmental Health)
Mitsumasa Kishimoto (Kyorin University)
Management information
Registered date
| 2021 | Year | 06 | Month | 30 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051068
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
