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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
Sponsor: AbbVie
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.
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
Key Details
Gender
All
Age Range
15 Years - Any
Study Type
OBSERVATIONAL
Enrollment
308
Start Date
2022-12-19
Completion Date
2025-12-09
Last Updated
2026-10-05
Healthy Volunteers
No
Conditions
Locations (114)
Anjou Kousei Hospital /ID# 256207
Anjo-shi, Aichi-ken, Japan
Ichinomiyanishi Hospital /ID# 259498
Ichinomiya-shi, Aichi-ken, Japan
Aikawa Minnano-shinryojo /ID# 258447
Nagoya, Aichi-ken, Japan
Shimozato Clinic /ID# 261901
Nagoya, Aichi-ken, Japan
Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049
Nagoya, Aichi-ken, Japan
Yamada Coloproctology Clinic /ID# 259508
Niwa-gun, Aichi-ken, Japan
Toyohashi Municipal Hospital /ID# 267048
Toyohashi, Aichi-ken, Japan
Ieda Hospital /ID# 257012
Toyota-shi, Aichi-ken, Japan
Hachinohe City Hospital /ID# 256198
Hachinohe-shi, Aomori, Japan
Asahi General Hospital /ID# 258446
Asahi, Chiba, Japan
Chiba Clinic /ID# 257015
Chiba, Chiba, Japan
Nippon Medical Chiba Hokusoh Hospital /ID# 259505
Inzai-shi, Chiba, Japan
Tsujinaka Hospital - Kashiwanoha /ID# 257013
Kashiwa-shi, Chiba, Japan
Juntendo University Urayasu Hospital /ID# 265635
Urayasu, Chiba, Japan
Matsuyama Red Cross Hospital /ID# 260211
Matsuyama, Ehime, Japan
Kobayashi Clinic /ID# 265631
Chikugo-shi, Fukuoka, Japan
Fukuoka University Chikushi Hospital /ID# 255248
Chikushino-shi, Fukuoka, Japan
Sakemi clinic /ID# 261889
Fukuoka, Fukuoka, Japan
Tobata Kyoritsu Hospital /ID# 257043
Kitakyusyu-shi, Fukuoka, Japan
Hidaka Clinic of Coloproctology /ID# 252879
Kurume-shi, Fukuoka, Japan
Hoshi General Hospital /ID# 261292
Koriyama-shi, Fukushima, Japan
Southern Tohoku General Hospital /ID# 267043
Kōriyama, Fukushima, Japan
Fukutomi Icyo Clinic /ID# 267047
Gifu, Gifu, Japan
Gifu Municipal Hospital /ID# 255254
Gifu, Gifu, Japan
Gifu University Hospital /ID# 258435
Gifu, Gifu, Japan
Mori Surgical Clinic /ID# 258445
Ogaki-shi, Gifu, Japan
Chuno Kosei Hospital /ID# 263042
Seki-shi, Gifu, Japan
Gifu Prefectural Tajimi Hosp /ID# 260213
Tajimi-shi, Gifu, Japan
Kudo Gastroenterology Clinic /ID# 255251
Takasaki-shi, Gunma, Japan
National Hospital Organization Fukuyama Medical Center /ID# 255246
Fukuyama-shi, Hiroshima, Japan
Kaisei Clinic /ID# 258441
Hiroshima, Hiroshima, Japan
Hiroshima University Hospital /ID# 257045
Hiroshima, Hiroshima, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437
Sapporo, Hokkaido, Japan
Sapporo IBD Clinic /ID# 255255
Sapporo, Hokkaido, Japan
Kobe University Hospital /ID# 260212
Kobe, Hyōgo, Japan
Nishi-Kobe Medical Center /ID# 258433
Kobe, Hyōgo, Japan
Hida Endoscopy Clinic /ID# 255252
Nishinomiya-shi, Hyōgo, Japan
Hyogo Medical University Hospital /ID# 259500
Nishinomiya-shi, Hyōgo, Japan
Hitachinaka General Hospital /ID# 256209
Hitachi-Naka, Ibaraki, Japan
Tokyo Medical University Ibaraki Medical Center /ID# 260210
Inashiki-shi, Ibaraki, Japan
Koyama Memorial Hospital /ID# 256212
Kashima-shi, Ibaraki, Japan
Tsuchiura Kyodo General Hospital /ID# 260732
Tsuchiura-shi, Ibaraki, Japan
Kanazawa Red Cross Hospital /ID# 262653
Kanazawa, Ishikawa-ken, Japan
Takamatsu Red Cross Hospital /ID# 259493
Takamatsu, Kagawa-ken, Japan
Sameshima Hospital /ID# 256215
Kagoshima, Kagoshima-ken, Japan
Kagoshima IBD Gastroenterology Clinic /ID# 255191
Kagoshima, Kagoshima-ken, Japan
Atsugi Familly Clinic /ID# 259496
Atsugi-shi, Kanagawa, Japan
Gokeikai Ofuna Chuo Hospital /ID# 259502
Kamakura-shi, Kanagawa, Japan
Shin-Yurigaoka General Hospital /ID# 265634
Kawasaki-shi, Kanagawa, Japan
Kitasato University Hospital /ID# 267442
Sagamihara-shi, Kanagawa, Japan
Yokohama Municipal Citizen's Hospital /ID# 259503
Yokohama, Kanagawa, Japan
Saiseikai Yokohamashi Tobu /ID# 261896
Yokohama, Kanagawa, Japan
Koganecho Sukoyaka Clinic /ID# 257014
Yokohama, Kanagawa, Japan
Yokohama Totsukaekimae Clinic /ID# 259509
Yokohama, Kanagawa, Japan
Coloproctology Center Takano Hospital /ID# 257041
Kumamoto, Kumamoto, Japan
Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213
Kyoto, Kyoto, Japan
National Hospital Organization Kyoto Medical Center /ID# 259497
Kyoto, Kyoto, Japan
Mie University Hospital /ID# 257011
Tsu, Mie-ken, Japan
Yokkaichi Hazu Medical Center /ID# 257010
Yokkaichi-shi, Mie-ken, Japan
Tohoku Medical and Pharmaceutical University Hospital /ID# 265636
Sendai, Miyagi, Japan
Showa Inan General Hospital /ID# 258413
Komagane-shi, Nagano, Japan
Shinonoi General Hospital /ID# 261893
Nagano, Nagano, Japan
Nara Prefecture General Medical Center - Nara /ID# 256211
Nara, Nara, Japan
Nagaoka Red Cross Hospital /ID# 255250
Nagaoka-shi, Niigata, Japan
Yoneyama Clinic /ID# 256210
Niigata, Niigata, Japan
Ishida Clinic of IBD and Gastroenterology /ID# 252878
Ōita, Oita Prefecture, Japan
Okayama University Hospital /ID# 262651
Okayama, Okayama-ken, Japan
University of the Ryukyus Hospital /ID# 257044
Ginowan-shi, Okinawa, Japan
Naha City Hospital /ID# 255249
Naha, Okinawa, Japan
Nakagami Hospital /ID# 256214
Okinawa-shi, Okinawa, Japan
Urasoe General Hospital /ID# 267042
Urasoe, Okinawa, Japan
Sai Gastroenterology and Proctology Clinic /ID# 252880
Fujidera-shi, Osaka, Japan
Hirakata Kohsai Hospital /ID# 256216
Hirakata, Osaka, Japan
Kansai Medical University Hospital /ID# 255247
Hirakata-shi, Osaka, Japan
Kinshukai Infusion Clinic /ID# 253199
Osaka, Osaka, Japan
National Hospital Organization Osaka National Hospital /ID# 257042
Osaka, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 258319
Osaka, Osaka, Japan
Tane General Hospital /ID# 259495
Osaka, Osaka, Japan
Yoshino Medical Clinic /ID# 255192
Osaka, Osaka, Japan
Osaka Rosai Hospital /ID# 255244
Sakai-shi, Osaka, Japan
Toyonaka Municipal Hospital /ID# 258414
Toyonaka-shi, Osaka, Japan
Ohmori Toshihide gastro-intestinal Clinic /ID# 256205
Ageo-shi, Saitama, Japan
Kumagaya General Hospital /ID# 261294
Kumagaya-shi, Saitama, Japan
Shiga University of Medical Science Hospital /ID# 258323
Ōtsu, Shiga, Japan
Hamamatsu University Hospital /ID# 258438
Hamamatsu, Shizuoka, Japan
Kato Clinic /ID# 254489
Hamamatsu, Shizuoka, Japan
Kashiwabara Gastroenterology Clinic /ID# 261885
Hamamatsu, Shizuoka, Japan
Shizuoka Aoi Clinic /ID# 260219
Shizuoka, Shizuoka, Japan
NHO Shizuoka Medical Center /ID# 260214
Sunto-gun, Shizuoka, Japan
Dokkyo Medical University Hospital /ID# 257040
Mibu, Tochigi, Japan
Saiseikai Utsunomiya Hospital /ID# 254488
Utsunomiya, Tochigi, Japan
Juntendo University Hospital /ID# 259504
Bunkyo-ku, Tokyo, Japan
Ginza Central Clinic /ID# 256208
Chuo-ku, Tokyo, Japan
Koganei Tsurukame Clinic /ID# 260215
Koganei-shi, Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 258434
Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 261293
Mitaka-shi, Tokyo, Japan
Ohori IBD Clinic /ID# 255253
Setagaya-ku, Tokyo, Japan
Shinjuku Tsurukame Clinic /ID# 258443
Shibuya-ku, Tokyo, Japan
Showa University Hospital /ID# 261898
Shinagawa-ku, Tokyo, Japan
Tokyo Medical University Hospital /ID# 261291
Shinjuku-ku, Tokyo, Japan
Keio University Hospital /ID# 261899
Shinjuku-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 261887
Shinjuku-ku, Tokyo, Japan
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886
Shinjuku-ku, Tokyo, Japan
Tottori University Hospital /ID# 265633
Yonago, Tottori, Japan
Yokota Memorial Hospital /ID# 267044
Toyama, Toyama, Japan
Japanese Red Cross Wakayama Medical Center /ID# 255245
Wakayama, Wakayama, Japan
Wakayama Medical University Hospital /ID# 259506
Wakayama, Wakayama, Japan
Yamaguchi Red Cross Hospital /ID# 257016
Yamaguchi, Yamaguchi, Japan
Iwamoto Naika Onaka Clinic /ID# 261888
Kofu, Yamanashi, Japan
Aomori Prefectural Central Hospital /ID# 266719
Aomori, Japan
Hattori Clinic - Kumamoto /ID# 263978
Kumamoto, Japan
Nagasaki Harbor Medical Center /ID# 264425
Nagasaki, Japan
St. Luke's International Hospital /ID# 264301
Tokyo, Japan
The Jikei University Hospital /ID# 262652
Tokyo, Japan