Clinical trial NCT05791526: An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan
Official title: A Prospective Observational Study for Evaluation of Safety and Effectiveness of Rinvoq in Moderately to Severely Active Ulcerative Colitis; a Japanese Post-Marketing Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Keywords: Ulcerative colitis
UC
Rinvoq
Upadacitinib
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2023-03-30
Enrollment: 300
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: Adult participants with moderately to severely active Ulcerative colitis (UC)

Brief summary: Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon. This study will assess how safe and effective Rinvoq is in treating adult participants with moderate to severe ulcerative colitis (UC). Adverse events and change in disease activity will be assessed.

Rinvoq is a drug approved for the treatment of ulcerative colitis (UC). All study participants will receive Rinvoq as prescribed by their study doctor in accordance with approved local label. Approximately 300 adult 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 60 weeks.

There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.


Eligibility criteria: Inclusion Criteria:

* Participants diagnosed with moderately to severely active Ulcerative colitis (UC).
* Participants who are within 14 days from the commencement of Rinvoq treatment for UC.
* Participants who are administered the first dose of Rinvoq for UC after approval for UC in Japan.

Exclusion Criteria:

* Participants currently participating in registrational clinical trial.
* Participants for whom Rinvoq is contraindicated.
* Participants that have been previously exposed to Rinvoq.

Primary outcomes:
measure: Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR)
timeFrame: Up to 60 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anjo-shi
country: Japan
facility: Anjou Kousei Hospital /ID# 256207
state: Aichi
city: Ichinomiya-shi
country: Japan
facility: Ichinomiyanishi Hospital /ID# 259498
state: Aichi
city: Nagoya-shi
country: Japan
facility: Aikawa Minnano-shinryojo /ID# 258447
state: Aichi
city: Nagoya-shi
country: Japan
facility: Shimozato Clinic /ID# 261901
state: Aichi
city: Nagoya-shi
country: Japan
facility: Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049
state: Aichi
city: Niwa-gun
country: Japan
facility: Yamada Coloproctology Clinic /ID# 259508
state: Aichi
city: Toyota-shi
country: Japan
facility: Ieda Hospital /ID# 257012
state: Aichi
city: Asahi-shi
country: Japan
facility: Asahi General Hospital /ID# 258446
state: Chiba
city: Chiba-shi
country: Japan
facility: Chiba Clinic /ID# 257015
state: Chiba
city: Inzai-shi
country: Japan
facility: Nippon Medical Chiba Hokusoh Hospital /ID# 259505
state: Chiba
city: Kashiwa-shi
country: Japan
facility: Tsujinaka Hospital Kashiwanoha /ID# 257013
state: Chiba
city: Urayasu
country: Japan
facility: Juntendo University Urayasu Hospital /ID# 265635
state: Chiba
city: Matsuyama-shi
country: Japan
facility: Matsuyama Red Cross Hospital /ID# 260211
state: Ehime
city: Chikugo-shi
country: Japan
facility: Kobayashi Clinic /ID# 265631
state: Fukuoka
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital /ID# 255248
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Sakemi clinic /ID# 261889
state: Fukuoka
city: Kitakyusyu-shi
country: Japan
facility: Tobata Kyoritsu Hospital /ID# 257043
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Hidaka Clinic of Coloproctology /ID# 252879
state: Fukuoka
city: Koriyama City
country: Japan
facility: Hoshi General Hospital /ID# 261292
state: Fukushima
city: Gifu-shi
country: Japan
facility: Gifu Municipal Hospital /ID# 255254
state: Gifu
city: Gifu-shi
country: Japan
facility: Gifu University Hospital /ID# 258435
state: Gifu
city: Ogaki-shi
country: Japan
facility: Mori Surgical Clinic /ID# 258445
state: Gifu
city: Seki City
country: Japan
facility: Chuno Kosei Hospital /ID# 263042
state: Gifu
city: Tajimi-shi
country: Japan
facility: Gifu Prefectural Tajimi Hosp /ID# 260213
state: Gifu
city: Takasaki-shi
country: Japan
facility: Kudo Gastroenterology Clinic /ID# 255251
state: Gunma
city: Fukuyama-shi
country: Japan
facility: NHO Fukuyama Medical Center /ID# 255246
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Kaisei Clinic /ID# 258441
state: Hiroshima
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 257045
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Sapporo IBD Clinic /ID# 255255
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Kobe University Hospital /ID# 260212
state: Hyogo
city: Kobe-shi
country: Japan
facility: Nishi-Kobe Medical Center /ID# 258433
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hida Endoscopy Clinic /ID# 255252
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo Medical University Hospital /ID# 259500
state: Hyogo
city: Hitachinaka-shi
country: Japan
facility: Hitachinaka General Hospital /ID# 256209
state: Ibaraki
city: Inashiki-shi
country: Japan
facility: Tokyo Medical University Ibaraki Medical Center /ID# 260210
state: Ibaraki
city: Kashima City
country: Japan
facility: Koyama Memorial Hospital /ID# 256212
state: Ibaraki
city: Tsuchiura-shi
country: Japan
facility: Tsuchiura Kyodo General Hospital /ID# 260732
state: Ibaraki
city: Kanazawa-shi
country: Japan
facility: Kanazawa Red Cross Hospital /ID# 262653
state: Ishikawa
city: Takamatsu-shi
country: Japan
facility: Takamatsu Red Cross Hospital /ID# 259493
state: Kagawa
city: Kagoshima-shi
country: Japan
facility: Sameshima Hospital /ID# 256215
state: Kagoshima
city: Kagoshima-shi
country: Japan
facility: Kagoshima IBD Gastroenterology Clinic /ID# 255191
state: Kagoshima
city: Atsugi-shi
country: Japan
facility: Atsugi Familly Clinic /ID# 259496
state: Kanagawa
city: Kamakura-shi
country: Japan
facility: Gokeikai Ofuna Chuo Hospital /ID# 259502
state: Kanagawa
city: Kawasaki City
country: Japan
facility: Shin-Yurigaoka General Hospital /ID# 265634
state: Kanagawa
city: Sagamihara
country: Japan
facility: Kitasato University Hospital /ID# 267442
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Municipal Citizen's Hospital /ID# 259503
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Saiseikai Yokohamashi Tobu /ID# 261896
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Koganecho Sukoyaka Clinic /ID# 257014
state: Kanagawa
city: Yokohama-shi
country: Japan
facility: Yokohama Totsukaekimae Clinic /ID# 259509
state: Kanagawa
city: Kumamoto-shi
country: Japan
facility: Coloproctology Center Takano Hospital /ID# 257041
state: Kumamoto
city: Kyoto-shi
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213
state: Kyoto
city: Kyoto-shi
country: Japan
facility: National Hospital Organization Kyoto Medical Center /ID# 259497
state: Kyoto
city: Tsu-shi
country: Japan
facility: Mie University Hospital /ID# 257011
state: Mie
city: Yokkaichi-shi
country: Japan
facility: Yokkaichi Hazu Medical Center /ID# 257010
state: Mie
city: Sendai
country: Japan
facility: Tohoku Pharmaceutical University Hospital /ID# 265636
state: Miyagi
city: Komagane-shi
country: Japan
facility: Showa Inan General Hospital /ID# 258413
state: Nagano
city: Nagano-shi
country: Japan
facility: Shinonoi General Hospital /ID# 261893
state: Nagano
city: Nara-shi
country: Japan
facility: Nara Prefecture General Medical Center /ID# 256211
state: Nara
city: Nagaoka-shi
country: Japan
facility: Nagaoka Red Cross Hospital /ID# 255250
state: Niigata
city: Niigata-shi
country: Japan
facility: Yoneyama Clinic /ID# 256210
state: Niigata
city: Oita-shi
country: Japan
facility: Ishida Clinic of IBD and Gastroenterology /ID# 252878
state: Oita
city: Naha
country: Japan
facility: Naha City Hospital /ID# 255249
state: Okinawa
city: Nakagami-gun
country: Japan
facility: University of the Ryukyus Hospital /ID# 257044
state: Okinawa
city: Okinawa-shi
country: Japan
facility: Nakagami Hospital /ID# 256214
state: Okinawa
city: Fujidera-shi
country: Japan
facility: Sai Gastroenterology and Proctology Clinic /ID# 252880
state: Osaka
city: Hirakata-shi
country: Japan
facility: Kansai Medical University Hospital /ID# 255247
state: Osaka
city: Hirakata
country: Japan
facility: Hirakata Kohsai Hospital /ID# 256216
state: Osaka
city: Osaka-shi
country: Japan
facility: Kinshukai Infusion Clinic /ID# 253199
state: Osaka
city: Osaka-shi
country: Japan
facility: National Hospital Organization Osaka National Hospital /ID# 257042
state: Osaka
city: Osaka-shi
country: Japan
facility: Osaka Metropolitan University Hospital /ID# 258319
state: Osaka
city: Osaka-shi
country: Japan
facility: Tane General Hospital /ID# 259495
state: Osaka
city: Osaka-shi
country: Japan
facility: Yoshino Medical Clinic /ID# 255192
state: Osaka
city: Sakai-shi
country: Japan
facility: Osaka Rosai Hospital /ID# 255244
state: Osaka
city: Toyonaka-shi
country: Japan
facility: Toyonaka Municipal Hospital /ID# 258414
state: Osaka
city: Ageo-shi
country: Japan
facility: Ohmori Toshihide gastro-intestinal Clinic /ID# 256205
state: Saitama
city: Kumagaya-shi
country: Japan
facility: Kumagaya General Hospital /ID# 261294
state: Saitama
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital /ID# 258323
state: Shiga
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu University Hospital /ID# 258438
state: Shizuoka
city: Hamamatsu-shi
country: Japan
facility: Kato Clinic /ID# 254489
state: Shizuoka
city: Hamamatsu-shi
country: Japan
facility: Kashiwabara Gastroenterology Clinic /ID# 261885
state: Shizuoka
city: Shizuoka-shi
country: Japan
facility: Shizuoka Aoi Clinic /ID# 260219
state: Shizuoka
city: Sunto-gun
country: Japan
facility: NHO Shizuoka Medical Center /ID# 260214
state: Shizuoka
city: Mibu
country: Japan
facility: Dokkyo Medical University Hospital /ID# 257040
state: Tochigi
city: Utsunomiya-shi
country: Japan
facility: Saiseikai Utsunomiya Hospital /ID# 254488
state: Tochigi
city: Bunkyo-ku
country: Japan
facility: Juntendo University Hospital /ID# 259504
state: Tokyo
city: Chuo-ku
country: Japan
facility: Ginza Central Clinic /ID# 256208
state: Tokyo
city: Koganei-shi
country: Japan
facility: Koganei Tsurukame Clinic /ID# 260215
state: Tokyo
city: Minato-ku
country: Japan
facility: The Jikei University Hospital /ID# 262652
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital /ID# 258434
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Ohori IBD Clinic /ID# 255253
state: Tokyo
city: Shibuya-ku
country: Japan
facility: Shinjuku Tsurukame Clinic /ID# 258443
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Showa University Hospital /ID# 261898
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Medical University Hospital /ID# 261291
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Keio University Hospital /ID# 261899
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Tokyo Women's Medical University Hospital /ID# 261887
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886
state: Tokyo
city: Toyama-shi
country: Japan
facility: Yokota Memorial Hospital /ID# 267044
state: Toyama
city: Wakayama-shi
country: Japan
facility: Japanese Red Cross Wakayama Medical Center /ID# 255245
state: Wakayama
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital /ID# 259506
state: Wakayama
city: Yamaguchi-shi
country: Japan
facility: Yamaguchi Red Cross Hospital /ID# 257016
state: Yamaguchi
city: Kofu-shi
country: Japan
facility: Iwamoto Naika Onaka Clinic /ID# 261888
state: Yamanashi
city: Hachinohe-shi
country: Japan
facility: Hachinohe City Hospital /ID# 256198
city: Kumamoto
country: Japan
facility: Hattori Clinic /ID# 263978
city: Mitaka
country: Japan
facility: Kyorin University - Mitaka Campus /ID# 261293
city: Nagasaki
country: Japan
facility: Nagasaki Harbor Medical Center /ID# 264425
city: Okayama
country: Japan
facility: Okayama University Hospital /ID# 262651
city: Tokyo
country: Japan
facility: St. Luke's International Hospital /ID# 264301
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: