Clinical trial NCT06023030: An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants With Moderate to Severe Active Crohn's Disease (CD) in Japan
Official title: A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Crohn's Disease
Keywords: Crohn's disease
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-09-05
Enrollment: 240
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children and Adult participants with Crohn's disease (CD) in Japan.

Brief summary: Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 participants will be enrolled in Japan.

Participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 64 weeks.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.


Eligibility criteria: Inclusion Criteria:

* Diagnosed with moderately to severely active Crohn's disease (CD).
* Has been prescribed upadacitinib for CD as per most current local approved label after its approval for CD in Japan.
* Within 14 days from the commencement of upadacitinib induction treatment for CD at the participating institution.

Exclusion Criteria:

* Currently participating in another interventional clinical research.
* Participants for whom upadacitinib is contraindicated.
* Has been treated with upadacitinib for CD before and continue treatment with upadacitinib for CD at the participation to this study.

Primary outcomes:
measure: Percentage of Participants with Drug Related Serious Infections
timeFrame: Up to 64 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anjo-shi
country: Japan
facility: Anjou Kousei Hospital /ID# 261872
state: Aichi
city: Handa
country: Japan
facility: Handa City Hospital /ID# 270446
state: Aichi
city: Nagakute
country: Japan
facility: Aichi Medical University Hospital /ID# 261871
state: Aichi
city: Nagoya
country: Japan
facility: Masuko Memorial Hospital /ID# 267420
state: Aichi
city: Nagoya
country: Japan
facility: Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya City University Hospital /ID# 275588
state: Aichi
city: Toyohashi
country: Japan
facility: Toyohashi Municipal Hospital /ID# 274975
state: Aichi
city: Toyota-shi
country: Japan
facility: Ieda Hospital /ID# 259754
state: Aichi
city: Hachinohe
country: Japan
facility: Hachinohe City Hospital /ID# 264183
state: Aomori
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha /ID# 262648
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 266717
state: Ehime
city: Uwajima
country: Japan
facility: Uwajima City Hospital /ID# 273444
state: Ehime
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital /ID# 262686
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Kitakyushu Municipal Medical Center /ID# 276257
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Tobata Kyoritsu Hospital /ID# 273558
state: Fukuoka
city: Kitakyushu
country: Japan
facility: Steel Memorial Yahata Hospital /ID# 272713
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Hakuai Clinic /ID# 261876
state: Fukuoka
city: Kurume
country: Japan
facility: Hidaka Colon Proctology Clinic /ID# 268867
state: Fukuoka
city: Onga-gun
country: Japan
facility: Ashiya Central Hospital /ID# 275324
state: Fukuoka
city: Koriyama
country: Japan
facility: Southern Tohoku General Hospital /ID# 270447
state: Fukushima
city: Kakamigahara-shi
country: Japan
facility: Sakura Clinic /ID# 268344
state: Gifu
city: Fukuyama-shi
country: Japan
facility: NHO Fukuyama Medical Center /ID# 261873
state: Hiroshima
city: Hatsukaichi
country: Japan
facility: JA Hiroshima General Hospital /ID# 264432
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Kaisei Clinic /ID# 261883
state: Hiroshima
city: Ako
country: Japan
facility: Ako-City Hospital /ID# 271276
state: Hyogo
city: Himeji
country: Japan
facility: Himeji Chuo Hospital /ID# 272714
state: Hyogo
city: Itami
country: Japan
facility: Itami City Hospital /ID# 276258
state: Hyogo
city: Kobe-shi
country: Japan
facility: Aoyama Clinic /ID# 262658
state: Hyogo
city: Kobe-shi
country: Japan
facility: Kobe City Medical Center General Hospital /ID# 270950
state: Hyogo
city: Nishinomiya
country: Japan
facility: Hyogo Medical University Hospital /ID# 267383
state: Hyogo
city: Ono
country: Japan
facility: Kita-Harima Medical Center /ID# 276256
state: Hyogo
city: 姫路市
country: Japan
facility: Hyogo Prefectural Harima-Himeji General Medical Center /ID# 274528
state: Hyogo
city: Tsukuba-shi
country: Japan
facility: Tsukuba Endoscopy clinic /ID# 261880
state: Ibaraki
city: Kanazawa
country: Japan
facility: National Hospital Organization Kanazawa Medical Center /ID# 268820
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Maeda Hospital /ID# 275554
state: Kagawa
city: Takamatsu
country: Japan
facility: Takamatsu Red Cross Hospital /ID# 268823
state: Kagawa
city: Isehara
country: Japan
facility: Tokai University Hospital /ID# 270949
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital /ID# 262649
state: Kanagawa
city: Odawara-shi
country: Japan
facility: Shimizuogimachi Clinic /ID# 276278
state: Kanagawa
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 276524
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital /ID# 267375
state: Kanagawa
city: Yokohama
country: Japan
facility: Inoue Gastroenterology Clinic /ID# 275555
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohama Tobu Hospital /ID# 264186
state: Kanagawa
city: Kochi City
country: Japan
facility: Chikamori Hospital /ID# 267382
state: Kochi
city: Kumamoto-shi
country: Japan
facility: Coloproctology Center Takano Hospital /ID# 268868
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660
state: Kyoto
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Kyoto Medical Center /ID# 265461
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 262656
state: Mie
city: Yokkaichi-shi
country: Japan
facility: Yokkaichi Hazu Medical Center /ID# 260140
state: Mie
city: Nagano-shi
country: Japan
facility: Nagano Municipal Hospital /ID# 262627
state: Nagano
city: Nagasaki-shi
country: Japan
facility: Honda Internal Medicine and Endoscopy Clinic /ID# 275628
state: Nagasaki
city: Oita-shi
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology /ID# 261884
state: Oita
city: Ginowan-shi
country: Japan
facility: University of the Ryukyus Hospital /ID# 264430
state: Okinawa
city: Naha
country: Japan
facility: Naha City Hospital /ID# 261875
state: Okinawa
city: Ibaraki-shi
country: Japan
facility: Seshimo Gastroy & Procto Clinic /ID# 271658
state: Osaka
city: Moriguchi City
country: Japan
facility: Moriguchi Keijinkai Hospital /ID# 268821
state: Osaka
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic /ID# 261332
state: Osaka
city: Osaka-shi
country: Japan
facility: National Hospital Organization Osaka National Hospital /ID# 264230
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 273559
state: Osaka
city: Osaka-shi
country: Japan
facility: Tane General Hospital /ID# 268871
state: Osaka
city: Sakai City
country: Japan
facility: Osaka Rosai Hospital /ID# 267379
state: Osaka
city: Takatsuki
country: Japan
facility: Fujita Gastroenterology Hospital /ID# 275410
state: Osaka
city: Ageo
country: Japan
facility: Ohmori Toshihide Gastrointestinal Clinic /ID# 276192
state: Saitama
city: Kawagoe
country: Japan
facility: Saitama Medical Center /ID# 270948
state: Saitama
city: Saitama-shi
country: Japan
facility: Tokitokai Tokito clinic /ID# 262661
state: Saitama
city: Tokorozawa
country: Japan
facility: Tokorozawa Proctogic Hospital /ID# 268870
state: Saitama
city: Hamamatsu-shi
country: Japan
facility: Kato Clinic /ID# 262650
state: Shizuoka
city: Shimizu
country: Japan
facility: Shizuoka Medical Center /ID# 275551
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Shizuoka Aoi Clinic /ID# 267376
state: Shizuoka
city: Sizuoka-shi
country: Japan
facility: Saigusa Clinic Of Coloproctolo /ID# 275627
state: Shizuoka
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital /ID# 266710
state: Tochigi
city: Utsunomiya-shi
country: Japan
facility: Saiseikai Utsunomiya Hospital /ID# 261878
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 265452
state: Tokyo
city: Chuo-ku
country: Japan
facility: Ginza Central Clinic /ID# 261881
state: Tokyo
city: Koganei-shi
country: Japan
facility: Koganei Tsurukame Clinic /ID# 271660
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Ohori IBD Clinic /ID# 261882
state: Tokyo
city: Shibuya
country: Japan
facility: Shinjuku Tsurukame Clinic /ID# 276485
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 262683
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women'S Medical University Hospital /ID# 274527
state: Tokyo
city: Sumida-ku
country: Japan
facility: The Fraternity Memorial Hospital /ID# 274976
state: Tokyo
city: Toyama-shi
country: Japan
facility: Yokota Memorial Hospital /ID# 266714
state: Toyama
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital /ID# 262685
state: Wakayama
city: Ube
country: Japan
facility: Sentohill Hospital /ID# 268869
state: Yamaguchi
city: Kofu
country: Japan
facility: Yamanashi Prefectural Central Hospital /ID# 274526
state: Yamanashi
city: Fukui
country: Japan
facility: Fukuiken Saiseikai Hospital /ID# 274835
city: Fukushima
country: Japan
facility: Fukushima Red Cross Hospital /ID# 275322
city: Gifu
country: Japan
facility: Gifu University Hospital /ID# 266711
city: Himeji
country: Japan
facility: Japanease Red Cross Society Himeji Hospital /ID# 275590
city: Kagoshima
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic /ID# 265505
city: Kochi
country: Japan
facility: Kuniyoshi Hospital /ID# 271878
city: Saga
country: Japan
facility: Saga-Ken Medical Centre Koseikan /ID# 274957
city: Saitama
country: Japan
facility: Saitama City Hospital /ID# 266716
city: Sapporo
country: Japan
facility: Sapporo Kosei General Hospital /ID# 267374
city: Tokyo
country: Japan
facility: Kitasato University Kitasato Institute Hospital /ID# 268345
city: Tokyo
country: Japan
facility: Tokyo Yamate Medical Center /ID# 275591
city: Tokyo
country: Japan
facility: Teikyo University Hospital /ID# 274525
city: Tokyo
country: Japan
facility: Teikyo University Hospital /ID# 274977
city: Toyonaka
country: Japan
facility: Municipal Toyonaka Hospital /ID# 266712
city: Wakayama
country: Japan
facility: Japanese Red Cross Society - Wakayama Medical Center /ID# 268822
city: Yamagata
country: Japan
facility: Yamagata Prefectural Central Hospital - Yamagata /ID# 268819
city: Yamaguchi
country: Japan
facility: Yamaguchi Red Cross Hospital /ID# 267381
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: