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
- Conditions
- Ulcerative Colitis
- Registration Number
- NCT05791526
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 300
- 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.
- Participants currently participating in registrational clinical trial.
- Participants for whom Rinvoq is contraindicated.
- Participants that have been previously exposed to Rinvoq.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence Percentage of Serious Infection Reported as Adverse Drug Reaction (ADR) Up to 60 weeks 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (108)
Kinshukai Infusion Clinic /ID# 253199
🇯🇵Osaka-shi, Osaka, Japan
National Hospital Organization Osaka National Hospital /ID# 257042
🇯🇵Osaka-shi, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 258319
🇯🇵Osaka-shi, Osaka, Japan
Kato Clinic /ID# 254489
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Hamamatsu University Hospital /ID# 258438
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Ichinomiyanishi Hospital /ID# 259498
🇯🇵Ichinomiya-shi, Aichi, Japan
Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049
🇯🇵Nagoya-shi, Aichi, Japan
Kobayashi Clinic /ID# 265631
🇯🇵Chikugo-shi, Fukuoka, Japan
Fukuoka University Chikushi Hospital /ID# 255248
🇯🇵Chikushino-shi, Fukuoka, Japan
Sakemi clinic /ID# 261889
🇯🇵Fukuoka-shi, Fukuoka, Japan
Hidaka Clinic of Coloproctology /ID# 252879
🇯🇵Kurume-shi, Fukuoka, Japan
Sapporo IBD Clinic /ID# 255255
🇯🇵Sapporo-shi, Hokkaido, Japan
Coloproctology Center Takano Hospital /ID# 257041
🇯🇵Kumamoto-shi, Kumamoto, Japan
Ohmori Toshihide gastro-intestinal Clinic /ID# 256205
🇯🇵Ageo-shi, Saitama, Japan
St. Luke's International Hospital /ID# 264301
🇯🇵Tokyo, Japan
The Jikei University Hospital /ID# 262652
🇯🇵Minato-ku, Tokyo, Japan
Yamada Coloproctology Clinic /ID# 259508
🇯🇵Niwa-gun, Aichi, Japan
Ieda Hospital /ID# 257012
🇯🇵Toyota-shi, Aichi, Japan
Kudo Gastroenterology Clinic /ID# 255251
🇯🇵Takasaki-shi, Gunma, Japan
Hiroshima University Hospital /ID# 257045
🇯🇵Hiroshima-shi, Hiroshima, Japan
Yokkaichi Hazu Medical Center /ID# 257010
🇯🇵Yokkaichi-shi, Mie, Japan
Osaka Rosai Hospital /ID# 255244
🇯🇵Sakai-shi, Osaka, Japan
NHO Shizuoka Medical Center /ID# 260214
🇯🇵Sunto-gun, Shizuoka, Japan
Iwamoto Naika Onaka Clinic /ID# 261888
🇯🇵Kofu-shi, Yamanashi, Japan
Anjou Kousei Hospital /ID# 256207
🇯🇵Anjo-shi, Aichi, Japan
Nippon Medical Chiba Hokusoh Hospital /ID# 259505
🇯🇵Inzai-shi, Chiba, Japan
Juntendo University Urayasu Hospital /ID# 265635
🇯🇵Urayasu, Chiba, Japan
Gifu Municipal Hospital /ID# 255254
🇯🇵Gifu-shi, Gifu, Japan
Aikawa Minnano-shinryojo /ID# 258447
🇯🇵Nagoya-shi, Aichi, Japan
Shimozato Clinic /ID# 261901
🇯🇵Nagoya-shi, Aichi, Japan
Matsuyama Red Cross Hospital /ID# 260211
🇯🇵Matsuyama-shi, Ehime, Japan
Tobata Kyoritsu Hospital /ID# 257043
🇯🇵Kitakyusyu-shi, Fukuoka, Japan
Mori Surgical Clinic /ID# 258445
🇯🇵Ogaki-shi, Gifu, Japan
Takamatsu Red Cross Hospital /ID# 259493
🇯🇵Takamatsu-shi, Kagawa, Japan
Saiseikai Yokohamashi Tobu /ID# 261896
🇯🇵Yokohama-shi, Kanagawa, Japan
National Hospital Organization Kyoto Medical Center /ID# 259497
🇯🇵Kyoto-shi, Kyoto, Japan
Mie University Hospital /ID# 257011
🇯🇵Tsu-shi, Mie, Japan
Ishida Clinic of IBD and Gastroenterology /ID# 252878
🇯🇵Oita-shi, Oita, Japan
Naha City Hospital /ID# 255249
🇯🇵Naha, Okinawa, Japan
University of the Ryukyus Hospital /ID# 257044
🇯🇵Nakagami-gun, Okinawa, Japan
Tane General Hospital /ID# 259495
🇯🇵Osaka-shi, Osaka, Japan
Saiseikai Utsunomiya Hospital /ID# 254488
🇯🇵Utsunomiya-shi, Tochigi, Japan
Asahi General Hospital /ID# 258446
🇯🇵Asahi-shi, Chiba, Japan
Chiba Clinic /ID# 257015
🇯🇵Chiba-shi, Chiba, Japan
Tsujinaka Hospital Kashiwanoha /ID# 257013
🇯🇵Kashiwa-shi, Chiba, Japan
Hoshi General Hospital /ID# 261292
🇯🇵Koriyama City, Fukushima, Japan
NHO Fukuyama Medical Center /ID# 255246
🇯🇵Fukuyama-shi, Hiroshima, Japan
Nishi-Kobe Medical Center /ID# 258433
🇯🇵Kobe-shi, Hyogo, Japan
Hyogo Medical University Hospital /ID# 259500
🇯🇵Nishinomiya-shi, Hyogo, Japan
Tsuchiura Kyodo General Hospital /ID# 260732
🇯🇵Tsuchiura-shi, Ibaraki, Japan
Shin-Yurigaoka General Hospital /ID# 265634
🇯🇵Kawasaki City, Kanagawa, Japan
Yokohama Municipal Citizen's Hospital /ID# 259503
🇯🇵Yokohama-shi, Kanagawa, Japan
Yokohama Totsukaekimae Clinic /ID# 259509
🇯🇵Yokohama-shi, Kanagawa, Japan
Nakagami Hospital /ID# 256214
🇯🇵Okinawa-shi, Okinawa, Japan
Toyonaka Municipal Hospital /ID# 258414
🇯🇵Toyonaka-shi, Osaka, Japan
Shiga University of Medical Science Hospital /ID# 258323
🇯🇵Otsu-shi, Shiga, Japan
Gifu University Hospital /ID# 258435
🇯🇵Gifu-shi, Gifu, Japan
Chuno Kosei Hospital /ID# 263042
🇯🇵Seki City, Gifu, Japan
Kaisei Clinic /ID# 258441
🇯🇵Hiroshima-shi, Hiroshima, Japan
Hida Endoscopy Clinic /ID# 255252
🇯🇵Nishinomiya-shi, Hyogo, Japan
Hitachinaka General Hospital /ID# 256209
🇯🇵Hitachinaka-shi, Ibaraki, Japan
Tokyo Medical University Ibaraki Medical Center /ID# 260210
🇯🇵Inashiki-shi, Ibaraki, Japan
Atsugi Familly Clinic /ID# 259496
🇯🇵Atsugi-shi, Kanagawa, Japan
Gokeikai Ofuna Chuo Hospital /ID# 259502
🇯🇵Kamakura-shi, Kanagawa, Japan
Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213
🇯🇵Kyoto-shi, Kyoto, Japan
Nagaoka Red Cross Hospital /ID# 255250
🇯🇵Nagaoka-shi, Niigata, Japan
Shizuoka Aoi Clinic /ID# 260219
🇯🇵Shizuoka-shi, Shizuoka, Japan
Koganei Tsurukame Clinic /ID# 260215
🇯🇵Koganei-shi, Tokyo, Japan
Shinjuku Tsurukame Clinic /ID# 258443
🇯🇵Shibuya-ku, Tokyo, Japan
Dokkyo Medical University Hospital /ID# 257040
🇯🇵Mibu, Tochigi, Japan
Juntendo University Hospital /ID# 259504
🇯🇵Bunkyo-ku, Tokyo, Japan
Ginza Central Clinic /ID# 256208
🇯🇵Chuo-ku, Tokyo, Japan
Wakayama Medical University Hospital /ID# 259506
🇯🇵Wakayama-shi, Wakayama, Japan
Okayama University Hospital /ID# 262651
🇯🇵Okayama, Japan
Keio University Hospital /ID# 261899
🇯🇵Shinjuku-ku, Tokyo, Japan
Kitasato University Kitasato Institute Hospital /ID# 258434
🇯🇵Minato-ku, Tokyo, Japan
Showa University Hospital /ID# 261898
🇯🇵Shinagawa-ku, Tokyo, Japan
Tokyo Women's Medical University Hospital /ID# 261887
🇯🇵Shinjuku-ku, Tokyo, Japan
Yokota Memorial Hospital /ID# 267044
🇯🇵Toyama-shi, Toyama, Japan
Japanese Red Cross Wakayama Medical Center /ID# 255245
🇯🇵Wakayama-shi, Wakayama, Japan
Hachinohe City Hospital /ID# 256198
🇯🇵Hachinohe-shi, Japan
Gifu Prefectural Tajimi Hosp /ID# 260213
🇯🇵Tajimi-shi, Gifu, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437
🇯🇵Sapporo-shi, Hokkaido, Japan
Kobe University Hospital /ID# 260212
🇯🇵Kobe-shi, Hyogo, Japan
Koyama Memorial Hospital /ID# 256212
🇯🇵Kashima City, Ibaraki, Japan
Kanazawa Red Cross Hospital /ID# 262653
🇯🇵Kanazawa-shi, Ishikawa, Japan
Sameshima Hospital /ID# 256215
🇯🇵Kagoshima-shi, Kagoshima, Japan
Kagoshima IBD Gastroenterology Clinic /ID# 255191
🇯🇵Kagoshima-shi, Kagoshima, Japan
Kitasato University Hospital /ID# 267442
🇯🇵Sagamihara, Kanagawa, Japan
Koganecho Sukoyaka Clinic /ID# 257014
🇯🇵Yokohama-shi, Kanagawa, Japan
Tohoku Pharmaceutical University Hospital /ID# 265636
🇯🇵Sendai, Miyagi, Japan
Showa Inan General Hospital /ID# 258413
🇯🇵Komagane-shi, Nagano, Japan
Shinonoi General Hospital /ID# 261893
🇯🇵Nagano-shi, Nagano, Japan
Nara Prefecture General Medical Center /ID# 256211
🇯🇵Nara-shi, Nara, Japan
Yoneyama Clinic /ID# 256210
🇯🇵Niigata-shi, Niigata, Japan
Sai Gastroenterology and Proctology Clinic /ID# 252880
🇯🇵Fujidera-shi, Osaka, Japan
Kansai Medical University Hospital /ID# 255247
🇯🇵Hirakata-shi, Osaka, Japan
Hirakata Kohsai Hospital /ID# 256216
🇯🇵Hirakata, Osaka, Japan
Yoshino Medical Clinic /ID# 255192
🇯🇵Osaka-shi, Osaka, Japan
Kumagaya General Hospital /ID# 261294
🇯🇵Kumagaya-shi, Saitama, Japan
Kashiwabara Gastroenterology Clinic /ID# 261885
🇯🇵Hamamatsu-shi, Shizuoka, Japan
Tokyo Medical University Hospital /ID# 261291
🇯🇵Shinjuku-ku, Tokyo, Japan
Ohori IBD Clinic /ID# 255253
🇯🇵Setagaya-ku, Tokyo, Japan
Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886
🇯🇵Shinjuku-ku, Tokyo, Japan
Yamaguchi Red Cross Hospital /ID# 257016
🇯🇵Yamaguchi-shi, Yamaguchi, Japan
Hattori Clinic /ID# 263978
🇯🇵Kumamoto, Japan
Kyorin University - Mitaka Campus /ID# 261293
🇯🇵Mitaka, Japan
Nagasaki Harbor Medical Center /ID# 264425
🇯🇵Nagasaki, Japan