Clinical trial NCT05029895: A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
Official title: 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)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Atopic Dermatitis
Keywords: Atopic Dermatitis
Atopic Eczema
Upadacitinib
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-09-01
Enrollment: 170
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adolescent participants receiving upadacitinib according to the product prescribing information for atopic dermatitis in Japan.

Brief 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 criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Prior treatment with upadacitinib
* Currently participating in another registrational clinical research study
* Participants for whom upadacitinib is contraindicated

Primary outcomes:
measure: Percentage of Participants with Serious Infection
timeFrame: 2 Years
Secondary outcomes:
measure: Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) including Safety Specification
timeFrame: 2 Years
measure: Percentage of Participants Reporting an Adverse Event (AE)/Adverse Drug Reaction (ADR) Related to Impact on Bone Growth
timeFrame: 2 Years
measure: Percentage of Participants Achieving Validated Investigator Global Assessment for Atopic Dermatitis (vlGA-AD) of 0 or 1
timeFrame: 2 Years
measure: Absolute Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)
timeFrame: Up to 2 Years
measure: Percent Change from Baseline in Worst Pruritus-Numeric Rating Scale (NRS)
timeFrame: Up to 2 Years
measure: Percentage of Participants Achieving an Improvement in Worst Pruritus-NRS >=4
timeFrame: 2 Years
measure: Percentage of Participants Achieving Worst Pruritus-NRS 0/1
timeFrame: 2 Years
measure: Absolute Change from Baseline in Patient Oriented Eczema Measure (POEM) Score
timeFrame: 2 Years
measure: Percent Change from Baseline in POEM Score
timeFrame: 2 Years
measure: Percentage of Participants Achieving a Clinically Meaningful Improvement in POEM
timeFrame: 2 Years
Other outcomes:
Locations:
city: Asahi Owari
country: Japan
facility: Takeo Skin Clinic /ID# 248095
state: Aichi
city: Ichinomiya-shi
country: Japan
facility: Ichinomiya Municipal Hospital /ID# 245070
state: Aichi
city: Nagoya shi
country: Japan
facility: Nagoya City University Hospital /ID# 250809
state: Aichi
city: Nagoya-shi
country: Japan
facility: NHO Nagoya Medical Center /ID# 245069
state: Aichi
city: Obu-shi
country: Japan
facility: Aichi Children's Health and Medical Center /ID# 245357
state: Aichi
city: Akita City
country: Japan
facility: Noriko Dermatology Clinic /ID# 246626
state: Akita
city: Inzai-shi
country: Japan
facility: Nippon Medical Chiba Hokusoh Hospital /ID# 246627
state: Chiba
city: Yotsukaido-shi
country: Japan
facility: National Hospital Organization Shimoshizu National Hospital /ID# 245064
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 248739
state: Ehime
city: Fukuoka City
country: Japan
facility: Fukuoka Children's Hospital /ID# 245067
state: Fukuoka
city: Iizuka-shi
country: Japan
facility: Aso Iizuka Hospital /ID# 252145
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 248740
state: Fukuoka
city: Koriyama City
country: Japan
facility: Hoshi General Hospital /ID# 250959
state: Fukushima
city: Minokamo-shi
country: Japan
facility: Central Japan International Medical Center /ID# 246625
state: Gifu
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 245356
state: Hiroshima
city: Kitami-shi
country: Japan
facility: Kitami Red Cross Hospital /ID# 250838
state: Hokkaido
city: Obihiro-shi
country: Japan
facility: Takagi Dermatological Clinic Branch /ID# 241160
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Hosui General Medical Clinic /ID# 241881
state: Hokkaido
city: Sapporo
country: Japan
facility: Kobayashi Skin Clinic /ID# 248006
state: Hokkaido
city: Himeji City
country: Japan
facility: Hayano Pediatrician Clinic /ID# 250960
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 244052
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 250836
state: Hyogo
city: Kobe-shi
country: Japan
facility: Bito Dermatology Clinic /ID# 244093
state: Hyogo
city: Sichuan
country: Japan
facility: Maekawa Kids Clinic /ID# 249521
state: Hyogo
city: Mito-shi
country: Japan
facility: Mito Kyodo General Hospital /ID# 243745
state: Ibaraki
city: Marugame
country: Japan
facility: Takeoka Dermatology Clinic /ID# 240610
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Kagoshima City Hospital /ID# 252142
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Imamura General Hospital /ID# 249526
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital /ID# 248732
state: Kagoshima
city: Kawasaki
country: Japan
facility: Teikyo University Mizonokuchi Hospital /ID# 252146
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: National Hospital Organization Sagamihara National Hospital /ID# 243744
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Kanagawa Children's Medical Center /ID# 252144
state: Kanagawa
city: Tsu-shi
country: Japan
facility: National Mie Hospital /ID# 245066
state: Mie
city: Naha
country: Japan
facility: Naha City Hospital /ID# 245065
state: Okinawa
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 246020
state: Osaka
city: Moriguchi City
country: Japan
facility: Kansai Medical University Medical Center /ID# 250195
state: Osaka
city: Osaka-shi
country: Japan
facility: Japanese Red Cross Osaka Hospital /ID# 249524
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 245972
state: Osaka
city: Sakai-shi
country: Japan
facility: Hino Clinic /ID# 245975
state: Osaka
city: Takatsuki-shi
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital /ID# 251660
state: Osaka
city: Kasugabe City
country: Japan
facility: Okada Kodomonomori Clinic /ID# 248096
state: Saitama
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center /ID# 244695
state: Saitama
city: Koshigaya
country: Japan
facility: Dokkyo Medical University Saitama Medical Center /ID# 249525
state: Saitama
city: Nagahama-shi
country: Japan
facility: Nagahama Red Cross Hospital /ID# 252136
state: Shiga
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital /ID# 245969
state: Shiga
city: Kakegawa-shi
country: Japan
facility: Chutoen General Medical Center /Id# 248741
state: Shizuoka
city: Kakegawa-shi
country: Japan
facility: Chutoen General Medical Center /Id# 249522
state: Shizuoka
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital /ID# 245068
state: Tochigi
city: Hachioji-shi
country: Japan
facility: Tokyo Med Univ Hachioji Med Ct /ID# 250958
state: Tokyo
city: Setagaya-ku
country: Japan
facility: National Center for Child Health and Development /ID# 244696
state: Tokyo
city: Shibuya Ward
country: Japan
facility: Tokyo Metropolitan Hiroo Hospital /ID# 250837
state: Tokyo
city: Sumida-ku
country: Japan
facility: The Fraternity Memorial Hospital /ID# 245974
state: Tokyo
city: Toshima Ward
country: Japan
facility: Sugamo Sengoku Dermatology /ID# 247761
state: Tokyo
city: Tonami-shi
country: Japan
facility: Tonami General Hospital /ID# 247760
state: Toyama
city: Shingu City
country: Japan
facility: Suzuki Kids Clinic /ID# 243743
state: Wakayama
city: Hohu-shi
country: Japan
facility: Yamaguchi Grand Medical Center /ID# 251659
state: Yamaguchi
city: Hiratsuka-shi
country: Japan
facility: Hiratsuka City Hospital /ID# 245071
city: Okayama
country: Japan
facility: Okayama University Hospital /ID# 252141
city: Osaka
country: Japan
facility: Takatsuki General Hospital /ID# 242334
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: