Unique ID issued by UMIN | UMIN000052375 |
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Receipt number | R000059788 |
Scientific Title | Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis) |
Date of disclosure of the study information | 2023/12/20 |
Last modified on | 2023/11/17 09:19:13 |
Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis)
Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis)
Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis)
Dupixent Special Drug Use Investigation for long term use (Pediatric Atopic Dermatitis)
Japan |
Atopic Dermatitis
Pediatrics | Dermatology |
Others
NO
To collect information on the safety and effectiveness of long-term administration of Dupilumab in pediatric patients with atopic dermatitis not adequately controlled with existing therapies.
Safety,Efficacy
Safety:Incidence rates of adverse drug reactions, Safety specification items of Dupixent
Effectiveness:Investigator's Global Assessment (IGA), Peak weekly pruritus numeric rating scale(Worst-itch-NRS), Worst-scratch/itch-NRS for children under 6 years old, Body Surface Area of involvement of atopic dermatitis (BSA), Eczema Area and Severity Index (EASI)
Observational
6 | months-old | <= |
15 | years-old | > |
Male and Female
-Pediatrics aged 6 months to <15 years who newly start receiving the treatment with Dupixent
-Patients and/or the patient's legally acceptable representative who can provide informed consent and/or assent
-Subjects who are participating in or have been registered for clinical trials with therapeutic intervention to Dupixent
70
1st name | Masahiro |
Middle name | |
Last name | TAMURA |
Sanofi K.K.
Post-authorization regulatory studies, Medical Affairs
163-1488
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
03-6301-3867
Sanofi_Medical@sanofi.com
1st name | Public contact for Drug use surveillance |
Middle name | |
Last name | - |
Sanofi K.K.
Post-authorization regulatory studies, Medical Affairs
163-1488
3-20-2, Nishi Shinjuku, Shinjuku-ku, Tokyo 163-1488, Japan
03-6301-3867
Sanofi_Medical@sanofi.com
Sanofi K.K.
Sanofi K.K.
Profit organization
Japan Conference of Clinical Research
1-13-23 Minamiikebukuro Toshima-ku, Tokyo Japan
03-6868-7022
jccr-info@jccr.jp
NO
2023 | Year | 12 | Month | 20 | Day |
Unpublished
Preinitiation
2023 | Year | 09 | Month | 19 | Day |
2023 | Year | 11 | Month | 16 | Day |
2024 | Year | 01 | Month | 01 | Day |
2026 | Year | 06 | Month | 30 | Day |
Observational study
2023 | Year | 10 | Month | 02 | Day |
2023 | Year | 11 | Month | 17 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059788
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