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