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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants Receiving Upadacitinib | Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR) | An Adverse Event (AE) is defined as any untoward medical occurrence in a participant, which does not necessarily have a causal relationship with their treatment. Among AEs, an event whose causal relationship with the product cannot be ruled out is considered an adverse drug reaction. | Up to 60 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Adult participants with moderately to severely active Ulcerative colitis (UC)
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| Name | Affiliation | Role |
|---|---|---|
| ABBVIE INC. | AbbVie | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Anjou Kousei Hospital /ID# 256207 | Anjo-shi | Aichi-ken | 446-8602 | Japan | ||
| Ichinomiyanishi Hospital /ID# 259498 |
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| Ichinomiya-shi |
| Aichi-ken |
| 494-0001 |
| Japan |
| Aikawa Minnano-shinryojo /ID# 258447 | Nagoya | Aichi-ken | 458-0011 | Japan |
| Shimozato Clinic /ID# 261901 | Nagoya | Aichi-ken | 458-0044 | Japan |
| Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049 | Nagoya | Aichi-ken | 461-0004 | Japan |
| Yamada Coloproctology Clinic /ID# 259508 | Niwa-gun | Aichi-ken | 480-0147 | Japan |
| Toyohashi Municipal Hospital /ID# 267048 | Toyohashi | Aichi-ken | 441-8570 | Japan |
| Ieda Hospital /ID# 257012 | Toyota-shi | Aichi-ken | 470-1219 | Japan |
| Hachinohe City Hospital /ID# 256198 | Hachinohe-shi | Aomori | 031-8555 | Japan |
| Asahi General Hospital /ID# 258446 | Asahi | Chiba | 289-2511 | Japan |
| Chiba Clinic /ID# 257015 | Chiba | Chiba | 260-0018 | Japan |
| Nippon Medical Chiba Hokusoh Hospital /ID# 259505 | Inzai-shi | Chiba | 270-1613 | Japan |
| Tsujinaka Hospital - Kashiwanoha /ID# 257013 | Kashiwa-shi | Chiba | 277-0871 | Japan |
| Juntendo University Urayasu Hospital /ID# 265635 | Urayasu | Chiba | 279-0021 | Japan |
| Matsuyama Red Cross Hospital /ID# 260211 | Matsuyama | Ehime | 790-8524 | Japan |
| Kobayashi Clinic /ID# 265631 | Chikugo-shi | Fukuoka | 833-0005 | Japan |
| Fukuoka University Chikushi Hospital /ID# 255248 | Chikushino-shi | Fukuoka | 818-8502 | Japan |
| Sakemi clinic /ID# 261889 | Fukuoka | Fukuoka | 813-0003 | Japan |
| Tobata Kyoritsu Hospital /ID# 257043 | Kitakyusyu-shi | Fukuoka | 803-0836 | Japan |
| Hidaka Clinic of Coloproctology /ID# 252879 | Kurume-shi | Fukuoka | 839-0809 | Japan |
| Hoshi General Hospital /ID# 261292 | Koriyama-shi | Fukushima | 963-8501 | Japan |
| Southern Tohoku General Hospital /ID# 267043 | Kōriyama | Fukushima | 963-8563 | Japan |
| Fukutomi Icyo Clinic /ID# 267047 | Gifu | Gifu | 500-8175 | Japan |
| Gifu Municipal Hospital /ID# 255254 | Gifu | Gifu | 500-8323 | Japan |
| Gifu University Hospital /ID# 258435 | Gifu | Gifu | 501-1194 | Japan |
| Mori Surgical Clinic /ID# 258445 | Ogaki-shi | Gifu | 503-0031 | Japan |
| Chuno Kosei Hospital /ID# 263042 | Seki-shi | Gifu | 501-3802 | Japan |
| Gifu Prefectural Tajimi Hosp /ID# 260213 | Tajimi-shi | Gifu | 507-8522 | Japan |
| Kudo Gastroenterology Clinic /ID# 255251 | Takasaki-shi | Gunma | 370-0848 | Japan |
| National Hospital Organization Fukuyama Medical Center /ID# 255246 | Fukuyama-shi | Hiroshima | 720-8520 | Japan |
| Kaisei Clinic /ID# 258441 | Hiroshima | Hiroshima | 730-0017 | Japan |
| Hiroshima University Hospital /ID# 257045 | Hiroshima | Hiroshima | 734-8551 | Japan |
| Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437 | Sapporo | Hokkaido | 060-0033 | Japan |
| Sapporo IBD Clinic /ID# 255255 | Sapporo | Hokkaido | 064-0919 | Japan |
| Kobe University Hospital /ID# 260212 | Kobe | Hyōgo | 650-0017 | Japan |
| Nishi-Kobe Medical Center /ID# 258433 | Kobe | Hyōgo | 651-2273 | Japan |
| Hida Endoscopy Clinic /ID# 255252 | Nishinomiya-shi | Hyōgo | 662-0973 | Japan |
| Hyogo Medical University Hospital /ID# 259500 | Nishinomiya-shi | Hyōgo | 663-8501 | Japan |
| Hitachinaka General Hospital /ID# 256209 | Hitachi-Naka | Ibaraki | 312-0057 | Japan |
| Tokyo Medical University Ibaraki Medical Center /ID# 260210 | Inashiki-shi | Ibaraki | 300-0332 | Japan |
| Koyama Memorial Hospital /ID# 256212 | Kashima-shi | Ibaraki | 314-0030 | Japan |
| Tsuchiura Kyodo General Hospital /ID# 260732 | Tsuchiura-shi | Ibaraki | 300-0053 | Japan |
| Kanazawa Red Cross Hospital /ID# 262653 | Kanazawa | Ishikawa-ken | 921-8162 | Japan |
| Takamatsu Red Cross Hospital /ID# 259493 | Takamatsu | Kagawa-ken | 760-0017 | Japan |
| Sameshima Hospital /ID# 256215 | Kagoshima | Kagoshima-ken | 892-0846 | Japan |
| Kagoshima IBD Gastroenterology Clinic /ID# 255191 | Kagoshima | Kagoshima-ken | 8920804 | Japan |
| Atsugi Familly Clinic /ID# 259496 | Atsugi-shi | Kanagawa | 243-0018 | Japan |
| Gokeikai Ofuna Chuo Hospital /ID# 259502 | Kamakura-shi | Kanagawa | 247-0056 | Japan |
| Shin-Yurigaoka General Hospital /ID# 265634 | Kawasaki-shi | Kanagawa | 215-0026 | Japan |
| Kitasato University Hospital /ID# 267442 | Sagamihara-shi | Kanagawa | 252-0375 | Japan |
| Yokohama Municipal Citizen's Hospital /ID# 259503 | Yokohama | Kanagawa | 221-0855 | Japan |
| Saiseikai Yokohamashi Tobu /ID# 261896 | Yokohama | Kanagawa | 230-0012 | Japan |
| Koganecho Sukoyaka Clinic /ID# 257014 | Yokohama | Kanagawa | 232-0003 | Japan |
| Yokohama Totsukaekimae Clinic /ID# 259509 | Yokohama | Kanagawa | 244-0003 | Japan |
| Coloproctology Center Takano Hospital /ID# 257041 | Kumamoto | Kumamoto | 862-0971 | Japan |
| Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213 | Kyoto | Kyoto | 605-0981 | Japan |
| National Hospital Organization Kyoto Medical Center /ID# 259497 | Kyoto | Kyoto | 612-8555 | Japan |
| Mie University Hospital /ID# 257011 | Tsu | Mie-ken | 514-8507 | Japan |
| Yokkaichi Hazu Medical Center /ID# 257010 | Yokkaichi-shi | Mie-ken | 510-0016 | Japan |
| Tohoku Medical and Pharmaceutical University Hospital /ID# 265636 | Sendai | Miyagi | 983-8512 | Japan |
| Showa Inan General Hospital /ID# 258413 | Komagane-shi | Nagano | 3994117 | Japan |
| Shinonoi General Hospital /ID# 261893 | Nagano | Nagano | 388-8004 | Japan |
| Nara Prefecture General Medical Center - Nara /ID# 256211 | Nara | Nara | 630-8581 | Japan |
| Nagaoka Red Cross Hospital /ID# 255250 | Nagaoka-shi | Niigata | 940-2085 | Japan |
| Yoneyama Clinic /ID# 256210 | Niigata | Niigata | 950-2028 | Japan |
| Ishida Clinic of IBD and Gastroenterology /ID# 252878 | Ōita | Oita Prefecture | 870-0823 | Japan |
| Okayama University Hospital /ID# 262651 | Okayama | Okayama-ken | 700-8558 | Japan |
| University of the Ryukyus Hospital /ID# 257044 | Ginowan-shi | Okinawa | 901-2725 | Japan |
| Naha City Hospital /ID# 255249 | Naha | Okinawa | 902-0061 | Japan |
| Nakagami Hospital /ID# 256214 | Okinawa-shi | Okinawa | 904-2195 | Japan |
| Urasoe General Hospital /ID# 267042 | Urasoe | Okinawa | 901-2132 | Japan |
| Sai Gastroenterology and Proctology Clinic /ID# 252880 | Fujidera-shi | Osaka | 583-0027 | Japan |
| Hirakata Kohsai Hospital /ID# 256216 | Hirakata | Osaka | 573-0153 | Japan |
| Kansai Medical University Hospital /ID# 255247 | Hirakata-shi | Osaka | 573-1191 | Japan |
| Kinshukai Infusion Clinic /ID# 253199 | Osaka | Osaka | 530-0011 | Japan |
| National Hospital Organization Osaka National Hospital /ID# 257042 | Osaka | Osaka | 540-0006 | Japan |
| Osaka Metropolitan University Hospital /ID# 258319 | Osaka | Osaka | 545-8586 | Japan |
| Tane General Hospital /ID# 259495 | Osaka | Osaka | 550-0025 | Japan |
| Yoshino Medical Clinic /ID# 255192 | Osaka | Osaka | 553-0002 | Japan |
| Osaka Rosai Hospital /ID# 255244 | Sakai-shi | Osaka | 591-8025 | Japan |
| Toyonaka Municipal Hospital /ID# 258414 | Toyonaka-shi | Osaka | 560-0055 | Japan |
| Ohmori Toshihide gastro-intestinal Clinic /ID# 256205 | Ageo-shi | Saitama | 362-0075 | Japan |
| Kumagaya General Hospital /ID# 261294 | Kumagaya-shi | Saitama | 331-0074 | Japan |
| Shiga University of Medical Science Hospital /ID# 258323 | Ōtsu | Shiga | 520-2192 | Japan |
| Hamamatsu University Hospital /ID# 258438 | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Kato Clinic /ID# 254489 | Hamamatsu | Shizuoka | 432-8061 | Japan |
| Kashiwabara Gastroenterology Clinic /ID# 261885 | Hamamatsu | Shizuoka | 433-8113 | Japan |
| Shizuoka Aoi Clinic /ID# 260219 | Shizuoka | Shizuoka | 420-0881 | Japan |
| NHO Shizuoka Medical Center /ID# 260214 | Sunto-gun | Shizuoka | 411-8611 | Japan |
| Dokkyo Medical University Hospital /ID# 257040 | Mibu | Tochigi | 321-0293 | Japan |
| Saiseikai Utsunomiya Hospital /ID# 254488 | Utsunomiya | Tochigi | 321-0974 | Japan |
| Juntendo University Hospital /ID# 259504 | Bunkyo-ku | Tokyo | 113-8431 | Japan |
| Ginza Central Clinic /ID# 256208 | Chuo-ku | Tokyo | 104-0061 | Japan |
| Koganei Tsurukame Clinic /ID# 260215 | Koganei-shi | Tokyo | 184-0004 | Japan |
| Kitasato University Kitasato Institute Hospital /ID# 258434 | Minato-ku | Tokyo | 108-8642 | Japan |
| Kyorin University Hospital /ID# 261293 | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Ohori IBD Clinic /ID# 255253 | Setagaya-ku | Tokyo | 155-0032 | Japan |
| Shinjuku Tsurukame Clinic /ID# 258443 | Shibuya-ku | Tokyo | 151-0053 | Japan |
| Showa University Hospital /ID# 261898 | Shinagawa-ku | Tokyo | 142-8666 | Japan |
| Tokyo Medical University Hospital /ID# 261291 | Shinjuku-ku | Tokyo | 160-0023 | Japan |
| Keio University Hospital /ID# 261899 | Shinjuku-ku | Tokyo | 160-8582 | Japan |
| Tokyo Women's Medical University Hospital /ID# 261887 | Shinjuku-ku | Tokyo | 162-8666 | Japan |
| Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886 | Shinjuku-ku | Tokyo | 169-0073 | Japan |
| Tottori University Hospital /ID# 265633 | Yonago | Tottori | 683-8504 | Japan |
| Yokota Memorial Hospital /ID# 267044 | Toyama | Toyama | 939-8085 | Japan |
| Japanese Red Cross Wakayama Medical Center /ID# 255245 | Wakayama | Wakayama | 640-8558 | Japan |
| Wakayama Medical University Hospital /ID# 259506 | Wakayama | Wakayama | 641-8510 | Japan |
| Yamaguchi Red Cross Hospital /ID# 257016 | Yamaguchi | Yamaguchi | 753-8519 | Japan |
| Iwamoto Naika Onaka Clinic /ID# 261888 | Kofu | Yamanashi | 400-0813 | Japan |
| Aomori Prefectural Central Hospital /ID# 266719 | Aomori | 030-0913 | Japan |
| Hattori Clinic - Kumamoto /ID# 263978 | Kumamoto | 860-0004 | Japan |
| Nagasaki Harbor Medical Center /ID# 264425 | Nagasaki | 850-0842 | Japan |
| St. Luke's International Hospital /ID# 264301 | Tokyo | 104-8560 | Japan |
| The Jikei University Hospital /ID# 262652 | Tokyo | 105-8461 | Japan |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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