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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000032807
Receipt No. R000037424
Official scientific title of the study Dupixent Special Drug Use Investigation for long term use
Date of disclosure of the study information 2018/06/11
Last modified on 2018/07/02

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Basic information
Official scientific title of the study Dupixent Special Drug Use Investigation for long term use
Title of the study (Brief title) Dupixent Special Drug Use Investigation for long term use
Region
Japan

Condition
Condition Atopic dermatitis
Classification by specialty
Dermatology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To collect safety and effectiveness information of Dupixent used in the post-marketing setting in patients with atopic dermatitis not adequately controlled with existing therapies.
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, Safety specification items of Dupixent, asthma attack
Effectiveness: Investigators global assessment (IGA), Peak weekly pruritus NRS
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 atopic dermatitis with inadequate response to conventional therapies
-Patients who newly start receiving the treatment with Dupixent
-Patients who can provide informed consent
Key exclusion criteria Subjects who are participating in or have been registered for clinical trials with therapeutic intervention to Dupixent
Target sample size 900

Research contact person
Name of lead principal investigator Katsuhisa SUZUKI
Organization Sanofi K.K.
Division name Post-authorization regulatory studies, Medical Affairs
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 Shoko TSUKUBE
Organization Sanofi K.K.
Division name Post-authorization regulatory studies, Medical Affairs
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
Name of secondary funder(s)

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 06 Month 11 Day

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2018 Year 04 Month 13 Day
Anticipated trial start date
2018 Year 07 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information Patient's backgrounds, Dupixent administration status, Previous and concomitant treatments against atopic dermatitis, Concomitant medications other than Atopic dermatitis treatment, Effectiveness evaluation items for Atopic dermatitis, Biomarkers, Patients reported outcomes, etc.

Management information
Registered date
2018 Year 05 Month 31 Day
Last modified on
2018 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037424

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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