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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032408
Receipt No. R000036960
Scientific Title KEVZARA Special Drug Use Investigation
Date of disclosure of the study information 2018/05/10
Last modified on 2019/04/02

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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
Email 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
Email Sanofi_Medical@sanofi.com

Sponsor
Institute Sanofi K.K.
Institute
Department

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 -
Email -

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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 02 Month 23 Day
Date of IRB
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
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
2019 Year 04 Month 02 Day


Link to view the page
URL(English) https://upload.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


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