A Post-Marketing Observational Study to Evaluate Safety and Effectiveness of Upadacitinib in Adolescent Patients Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)

Status: Recruiting
Location: See all (59) locations...
Study Type: Observational
SUMMARY

Atopic dermatitis (AD; also known as atopic eczema) is an inflammatory skin disease. The safety and effectiveness of upadacitinib for AD has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in Japan. Therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent AD participants age 12 to \<18 years old in Japan in the real-world setting. Upadacitinib is an approved drug being developed for the treatment of AD in adolescents in Japan. Around 170 participants age 12 to \<18 who are prescribed upadacitinib for the treatment of AD in routine clinical practice will be enrolled at multiple sites in Japan. Participants will receive oral upadacitinib as prescribed by their physician. Data from these participants will be collected for approximately 2 years. There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• Participants who are diagnosed with atopic dermatitis (AD).

• History of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for AD.

• Participants initiating upadacitinib for the treatment of AD in routine clinical practice.

• Body weight \>=30 kg at the start of dosing.

Locations
Other Locations
Japan
Noriko Dermatology Clinic /ID# 246626
RECRUITING
Akita
Takeo Skin Clinic /ID# 248095
RECRUITING
Asahi Owari
Fukuoka Children'S Hospital /ID# 245067
RECRUITING
Fukuoka
Tokyo Med Univ Hachioji Med Ct /ID# 250958
RECRUITING
Hachioji-shi
Hayano Pediatrician Clinic /ID# 250960
RECRUITING
Himeji-shi
Kansai Medical University Hospital /ID# 246020
RECRUITING
Hirakata-shi
Hiratsuka City Hospital /ID# 245071
RECRUITING
Hiratsuka-shi
Hiroshima University Hospital /ID# 245356
RECRUITING
Hiroshima
Yamaguchi Grand Medical Center /ID# 251659
RECRUITING
Hohu-shi
Ichinomiya Municipal Hospital /ID# 245070
RECRUITING
Ichinomiya-shi
Aso Iizuka Hospital /ID# 252145
RECRUITING
Iizuka-shi
Nippon Medical Chiba Hokusoh Hospital /ID# 246627
RECRUITING
Inzai-shi
Imamura General Hospital /ID# 249526
RECRUITING
Kagoshima
Kagoshima City Hospital /ID# 252142
RECRUITING
Kagoshima
Kagoshima University Hospital /ID# 248732
RECRUITING
Kagoshima
Chutoen General Medical Center /Id# 248741
RECRUITING
Kakegawa-shi
Chutoen General Medical Center /Id# 249522
RECRUITING
Kakegawa-shi
Okada Kodomonomori Clinic /ID# 248096
RECRUITING
Kasukabe-shi
Saitama Medical Center /ID# 244695
RECRUITING
Kawagoe
Teikyo University Mizonokuchi Hospital /ID# 252146
RECRUITING
Kawasaki
Kitami Red Cross Hospital /ID# 250838
RECRUITING
Kitami-shi
Bito Dermatology Clinic /ID# 244093
RECRUITING
Kobe
Kobe City Medical Center General Hospital /ID# 244052
RECRUITING
Kobe
Kobe City Medical Center General Hospital /ID# 250836
RECRUITING
Kobe
Hoshi General Hospital /ID# 250959
RECRUITING
Koriyama-shi
Dokkyo Medical University Saitama Medical Center /ID# 249525
RECRUITING
Koshigaya
Kurume University Hospital /ID# 248740
RECRUITING
Kurume-shi
Takeoka Dermatology Clinic /ID# 240610
RECRUITING
Marugame
Matsuyama Red Cross Hospital /ID# 248739
RECRUITING
Matsuyama
Dokkyo Medical University Hospital /ID# 245068
RECRUITING
Mibu
Central Japan International Medical Center /ID# 246625
RECRUITING
Minokamo-shi
Mito Kyodo General Hospital /ID# 243745
RECRUITING
Mito
Kansai Medical University Takii Hospital /ID# 250195
RECRUITING
Moriguchi
Nagahama Red Cross Hospital /ID# 252136
RECRUITING
Nagahama-shi
Nagoya City University Hospital /ID# 250809
RECRUITING
Nagoya
NHO Nagoya Medical Center /ID# 245069
RECRUITING
Nagoya
Naha City Hospital /ID# 245065
RECRUITING
Naha
Takagi Dermatological Clinic /ID# 241160
RECRUITING
Obihiro-shi
Aichi Children's Health and Medical Center /ID# 245357
RECRUITING
Obu-shi
Okayama University Hospital /ID# 252141
RECRUITING
Okayama
Japanese Red Cross Osaka Hospital /ID# 249524
RECRUITING
Osaka
Osaka Metropolitan University Hospital /ID# 245972
RECRUITING
Osaka
Takatsuki General Hospital /ID# 242334
RECRUITING
Osaka
Shiga University of Medical Science Hospital /ID# 245969
RECRUITING
Ōtsu
National Hospital Organization Sagamihara National Hospital /ID# 243744
RECRUITING
Sagamihara-shi
Hino Clinic /ID# 245975
RECRUITING
Sakai-shi
Hosui General Medical Clinic /ID# 241881
RECRUITING
Sapporo
Kobayashi Skin Clinic /ID# 248006
RECRUITING
Sapporo
National Center for Child Health and Development /ID# 244696
RECRUITING
Setagaya-ku
Tokyo Metropolitan Hiroo Hospital /ID# 250837
RECRUITING
Shibuya Ward
Suzuki Kids Clinic /ID# 243743
RECRUITING
Shingū
Maekawa Kids Clinic /ID# 249521
RECRUITING
Sichuan
Fraternity Memorial Hospital /ID# 245974
RECRUITING
Sumida-ku
Osaka Medical and Pharmaceutical University Hospital /ID# 251660
RECRUITING
Takatsuki-shi
Tonami General Hospital /ID# 247760
RECRUITING
Tonami-shi
Sugamo Sengoku Dermatology /ID# 247761
RECRUITING
Toshima Ward
National Mie Hospital /ID# 245066
RECRUITING
Tsu
Kanagawa Children's Medical Center /ID# 252144
RECRUITING
Yokohama
National Hospital Organization Shimoshizu National Hospital /ID# 245064
RECRUITING
Yotsukaido-shi
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2021-09-29
Estimated Completion Date: 2026-03
Participants
Target number of participants: 170
Treatments
Participants Receiving Upadacitinib
Participants receiving upadacitinib for atopic dermatitis.
Related Therapeutic Areas
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov