UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032408 |
|---|---|
| Receipt number | R000036960 |
| Scientific Title | KEVZARA Special Drug Use Investigation |
| Date of disclosure of the study information | 2018/05/10 |
| Last modified on | 2021/11/05 10:57:48 |
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Basic information
Public title
KEVZARA
Special Drug Use Investigation
Acronym
KEVZARA
Special Drug Use Investigation
Scientific Title
KEVZARA
Special Drug Use Investigation
Scientific Title:Acronym
KEVZARA
Special Drug Use Investigation
Region
| Japan |
Condition
Condition
rheumatoid arthritis
Classification by specialty
| Medicine in general | Clinical immunology | Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To collect safety and effectiveness information of long term use of KEVZARA in the real world post-marketing setting in patients with rheumatoid arthritis.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Safety: Incidence rates of adverse drug reactions and important risks (Serious infection including tuberculosis, intestinal perforation, serious hypersensitivity, interstitial pneumonia, reactivation of hepatitis B virus, serious hematologic disorder, hepatic disorder, malignancy, cardiovascular event)
Effectiveness: DAS28-CRP
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
-Patients with rheumatoid arthritis who have had an inadequate response to conventional treatments
-Patients who newly start receiving the treatment with KEVZARA
-Patients provided informed consent on a voluntary basis
Key exclusion criteria
-
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | SUZUKI |
Organization
Sanofi K.K.
Division name
Post-authorization regulatory studies, Medical Affairs
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
TEL
03-6301-3867
Sanofi_Medical@sanofi.com
Public contact
Name of contact person
| 1st name | Public contact for Drug use surveillance |
| Middle name | |
| Last name | - |
Organization
Sanofi K.K.
Division name
Post-authorization regulatory studies, Medical Affairs
Zip code
163-1488
Address
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
TEL
03-6301-3867
Homepage URL
Sanofi_Medical@sanofi.com
Sponsor or person
Institute
Sanofi K.K.
Institute
Department
Personal name
Funding Source
Organization
Sanofi K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Outsource: Asahi Kasei Pharma Corporation, Scope of works to be outsourced: Request and contract procedure to medical institution, Request for case registration, entering CRF and answering inquiries,and progress management
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Not applicable because of Drug use surveillance
Address
-
Tel
-
-
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
| 2018 | Year | 05 | Month | 10 | 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
1125
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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 02 | Month | 23 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 23 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient's backgrounds, History of biologicals for primary disease, KEVZARA administration status, Previous and concomitant medications for primary disease, Concomitant medications of non-primary disease, Concomitant non drug therapy, Laboratory data, Anti Sarilumab antibody, etc.
Management information
Registered date
| 2018 | Year | 04 | Month | 27 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036960
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
