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NCT05791526Completed

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

A Prospective Observational Study for Evaluation of Safety and Effectiveness of Rinvoq in Moderately to Severely Active Ulcerative Colitis; a Japanese Post-Marketing Study

Source: ClinicalTrials.gov · Last updated 5 Oct 2026

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
308 (actual)
First submitted
17 Mar 2023
Start date
19 Dec 2022
Primary completion date
9 Dec 2025
Lead sponsor
AbbVie
NCT number
NCT05791526

What you commit to

  • Study type: Observational
  • Participants enrolled: 308
  • From 19 Dec 2022 to the primary completion date, 9 Dec 2025
  • 114 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants that have been previously exposed to Rinvoq.

Other

  • Participants currently participating in registrational clinical trial.
  • Participants for whom Rinvoq is contraindicated.

Who the study is looking for

  • 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.

Age in the registry: 15 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (114)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ohmori Toshihide gastro-intestinal Clinic /ID# 256205
Coordinator of this site? Confirm its status
Ageo-shiJapanUnknown status
Anjou Kousei Hospital /ID# 256207
Coordinator of this site? Confirm its status
Anjo-shiJapanUnknown status
Aomori Prefectural Central Hospital /ID# 266719
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AomoriJapanUnknown status
Asahi General Hospital /ID# 258446
Coordinator of this site? Confirm its status
AsahiJapanUnknown status
Atsugi Familly Clinic /ID# 259496
Coordinator of this site? Confirm its status
Atsugi-shiJapanUnknown status
Juntendo University Hospital /ID# 259504
Coordinator of this site? Confirm its status
Bunkyo-kuJapanUnknown status
Chiba Clinic /ID# 257015
Coordinator of this site? Confirm its status
ChibaJapanUnknown status
Kobayashi Clinic /ID# 265631
Coordinator of this site? Confirm its status
Chikugo-shiJapanUnknown status
Fukuoka University Chikushi Hospital /ID# 255248
Coordinator of this site? Confirm its status
Chikushino-shiJapanUnknown status
Ginza Central Clinic /ID# 256208
Coordinator of this site? Confirm its status
Chuo-kuJapanUnknown status
Sai Gastroenterology and Proctology Clinic /ID# 252880
Coordinator of this site? Confirm its status
Fujidera-shiJapanUnknown status
Sakemi clinic /ID# 261889
Coordinator of this site? Confirm its status
FukuokaJapanUnknown status
National Hospital Organization Fukuyama Medical Center /ID# 255246
Coordinator of this site? Confirm its status
Fukuyama-shiJapanUnknown status
Gifu University Hospital /ID# 258435
Coordinator of this site? Confirm its status
GifuJapanUnknown status
Fukutomi Icyo Clinic /ID# 267047
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GifuJapanUnknown status
Gifu Municipal Hospital /ID# 255254
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GifuJapanUnknown status
University of the Ryukyus Hospital /ID# 257044
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Ginowan-shiJapanUnknown status
Hachinohe City Hospital /ID# 256198
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Hachinohe-shiJapanUnknown status
Kashiwabara Gastroenterology Clinic /ID# 261885
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HamamatsuJapanUnknown status
Kato Clinic /ID# 254489
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HamamatsuJapanUnknown status
Hamamatsu University Hospital /ID# 258438
Coordinator of this site? Confirm its status
HamamatsuJapanUnknown status
Hirakata Kohsai Hospital /ID# 256216
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HirakataJapanUnknown status
Kansai Medical University Hospital /ID# 255247
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Hirakata-shiJapanUnknown status
Kaisei Clinic /ID# 258441
Coordinator of this site? Confirm its status
HiroshimaJapanUnknown status
Hiroshima University Hospital /ID# 257045
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HiroshimaJapanUnknown status
Hitachinaka General Hospital /ID# 256209
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Hitachi-NakaJapanUnknown status
Ichinomiyanishi Hospital /ID# 259498
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Ichinomiya-shiJapanUnknown status
Tokyo Medical University Ibaraki Medical Center /ID# 260210
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Inashiki-shiJapanUnknown status
Nippon Medical Chiba Hokusoh Hospital /ID# 259505
Coordinator of this site? Confirm its status
Inzai-shiJapanUnknown status
Sameshima Hospital /ID# 256215
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KagoshimaJapanUnknown status
Kagoshima IBD Gastroenterology Clinic /ID# 255191
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KagoshimaJapanUnknown status
Gokeikai Ofuna Chuo Hospital /ID# 259502
Coordinator of this site? Confirm its status
Kamakura-shiJapanUnknown status
Kanazawa Red Cross Hospital /ID# 262653
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KanazawaJapanUnknown status
Koyama Memorial Hospital /ID# 256212
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Kashima-shiJapanUnknown status
Tsujinaka Hospital - Kashiwanoha /ID# 257013
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Kashiwa-shiJapanUnknown status
Shin-Yurigaoka General Hospital /ID# 265634
Coordinator of this site? Confirm its status
Kawasaki-shiJapanUnknown status
Tobata Kyoritsu Hospital /ID# 257043
Coordinator of this site? Confirm its status
Kitakyusyu-shiJapanUnknown status
Kobe University Hospital /ID# 260212
Coordinator of this site? Confirm its status
KobeJapanUnknown status
Nishi-Kobe Medical Center /ID# 258433
Coordinator of this site? Confirm its status
KobeJapanUnknown status
Iwamoto Naika Onaka Clinic /ID# 261888
Coordinator of this site? Confirm its status
KofuJapanUnknown status
Koganei Tsurukame Clinic /ID# 260215
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Koganei-shiJapanUnknown status
Showa Inan General Hospital /ID# 258413
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Komagane-shiJapanUnknown status
Southern Tohoku General Hospital /ID# 267043
Coordinator of this site? Confirm its status
KōriyamaJapanUnknown status
Hoshi General Hospital /ID# 261292
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Koriyama-shiJapanUnknown status
Kumagaya General Hospital /ID# 261294
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Kumagaya-shiJapanUnknown status
Coloproctology Center Takano Hospital /ID# 257041
Coordinator of this site? Confirm its status
KumamotoJapanUnknown status
Hattori Clinic - Kumamoto /ID# 263978
Coordinator of this site? Confirm its status
KumamotoJapanUnknown status
Hidaka Clinic of Coloproctology /ID# 252879
Coordinator of this site? Confirm its status
Kurume-shiJapanUnknown status
Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213
Coordinator of this site? Confirm its status
KyotoJapanUnknown status
National Hospital Organization Kyoto Medical Center /ID# 259497
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KyotoJapanUnknown status
Matsuyama Red Cross Hospital /ID# 260211
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MatsuyamaJapanUnknown status
Dokkyo Medical University Hospital /ID# 257040
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MibuJapanUnknown status
Kitasato University Kitasato Institute Hospital /ID# 258434
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Minato-kuJapanUnknown status
Kyorin University Hospital /ID# 261293
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Mitaka-shiJapanUnknown status
Shinonoi General Hospital /ID# 261893
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NaganoJapanUnknown status
Nagaoka Red Cross Hospital /ID# 255250
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Nagaoka-shiJapanUnknown status
Nagasaki Harbor Medical Center /ID# 264425
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NagasakiJapanUnknown status
Aikawa Minnano-shinryojo /ID# 258447
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NagoyaJapanUnknown status
Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049
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NagoyaJapanUnknown status
Shimozato Clinic /ID# 261901
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NagoyaJapanUnknown status
Naha City Hospital /ID# 255249
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NahaJapanUnknown status
Nara Prefecture General Medical Center - Nara /ID# 256211
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NaraJapanUnknown status
Yoneyama Clinic /ID# 256210
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NiigataJapanUnknown status
Hyogo Medical University Hospital /ID# 259500
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Nishinomiya-shiJapanUnknown status
Hida Endoscopy Clinic /ID# 255252
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Nishinomiya-shiJapanUnknown status
Yamada Coloproctology Clinic /ID# 259508
Coordinator of this site? Confirm its status
Niwa-gunJapanUnknown status
Mori Surgical Clinic /ID# 258445
Coordinator of this site? Confirm its status
Ogaki-shiJapanUnknown status
Ishida Clinic of IBD and Gastroenterology /ID# 252878
Coordinator of this site? Confirm its status
ŌitaJapanUnknown status
Okayama University Hospital /ID# 262651
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OkayamaJapanUnknown status
Nakagami Hospital /ID# 256214
Coordinator of this site? Confirm its status
Okinawa-shiJapanUnknown status
Kinshukai Infusion Clinic /ID# 253199
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OsakaJapanUnknown status
Yoshino Medical Clinic /ID# 255192
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
National Hospital Organization Osaka National Hospital /ID# 257042
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Tane General Hospital /ID# 259495
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Osaka Metropolitan University Hospital /ID# 258319
Coordinator of this site? Confirm its status
OsakaJapanUnknown status
Shiga University of Medical Science Hospital /ID# 258323
Coordinator of this site? Confirm its status
ŌtsuJapanUnknown status
Kitasato University Hospital /ID# 267442
Coordinator of this site? Confirm its status
Sagamihara-shiJapanUnknown status
Osaka Rosai Hospital /ID# 255244
Coordinator of this site? Confirm its status
Sakai-shiJapanUnknown status
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Sapporo IBD Clinic /ID# 255255
Coordinator of this site? Confirm its status
SapporoJapanUnknown status
Chuno Kosei Hospital /ID# 263042
Coordinator of this site? Confirm its status
Seki-shiJapanUnknown status
Tohoku Medical and Pharmaceutical University Hospital /ID# 265636
Coordinator of this site? Confirm its status
SendaiJapanUnknown status
Ohori IBD Clinic /ID# 255253
Coordinator of this site? Confirm its status
Setagaya-kuJapanUnknown status
Shinjuku Tsurukame Clinic /ID# 258443
Coordinator of this site? Confirm its status
Shibuya-kuJapanUnknown status
Showa University Hospital /ID# 261898
Coordinator of this site? Confirm its status
Shinagawa-kuJapanUnknown status
Keio University Hospital /ID# 261899
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Tokyo Women's Medical University Hospital /ID# 261887
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Tokyo Medical University Hospital /ID# 261291
Coordinator of this site? Confirm its status
Shinjuku-kuJapanUnknown status
Shizuoka Aoi Clinic /ID# 260219
Coordinator of this site? Confirm its status
ShizuokaJapanUnknown status
NHO Shizuoka Medical Center /ID# 260214
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Sunto-gunJapanUnknown status
Gifu Prefectural Tajimi Hosp /ID# 260213
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Tajimi-shiJapanUnknown status
Takamatsu Red Cross Hospital /ID# 259493
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TakamatsuJapanUnknown status
Kudo Gastroenterology Clinic /ID# 255251
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Takasaki-shiJapanUnknown status
St. Luke's International Hospital /ID# 264301
Coordinator of this site? Confirm its status
TokyoJapanUnknown status
The Jikei University Hospital /ID# 262652
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TokyoJapanUnknown status
Yokota Memorial Hospital /ID# 267044
Coordinator of this site? Confirm its status
ToyamaJapanUnknown status
Toyohashi Municipal Hospital /ID# 267048
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ToyohashiJapanUnknown status
Toyonaka Municipal Hospital /ID# 258414
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Toyonaka-shiJapanUnknown status
Ieda Hospital /ID# 257012
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Toyota-shiJapanUnknown status
Mie University Hospital /ID# 257011
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TsuJapanUnknown status
Tsuchiura Kyodo General Hospital /ID# 260732
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Tsuchiura-shiJapanUnknown status
Urasoe General Hospital /ID# 267042
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UrasoeJapanUnknown status
Juntendo University Urayasu Hospital /ID# 265635
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UrayasuJapanUnknown status
Saiseikai Utsunomiya Hospital /ID# 254488
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UtsunomiyaJapanUnknown status
Japanese Red Cross Wakayama Medical Center /ID# 255245
Coordinator of this site? Confirm its status
WakayamaJapanUnknown status
Wakayama Medical University Hospital /ID# 259506
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WakayamaJapanUnknown status
Yamaguchi Red Cross Hospital /ID# 257016
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YamaguchiJapanUnknown status
Yokkaichi Hazu Medical Center /ID# 257010
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Yokkaichi-shiJapanUnknown status
Saiseikai Yokohamashi Tobu /ID# 261896
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YokohamaJapanUnknown status
Koganecho Sukoyaka Clinic /ID# 257014
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YokohamaJapanUnknown status
Yokohama Municipal Citizen's Hospital /ID# 259503
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YokohamaJapanUnknown status
Yokohama Totsukaekimae Clinic /ID# 259509
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YokohamaJapanUnknown status
Tottori University Hospital /ID# 265633
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YonagoJapanUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.