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NCT05791526 Clinical Trial

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

Ulcerative Colitis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05791526
Other study ID # P22-962
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date December 19, 2022
Est. completion date November 30, 2025

Study information
Verified date April 2024
Source AbbVie
Contact AbbVie GK Clinical Trial Registration Desk
Phone +81-3-4577-1111
Email abbvie_jpn_info_clingov@abbvie.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date November 30, 2025
Est. primary completion date November 30, 2025
Accepts healthy volunteers No
Gender All
Age group 15 Years and older
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - Participants currently participating in registrational clinical trial. - Participants for whom Rinvoq is contraindicated. - Participants that have been previously exposed to Rinvoq.

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Ohmori Toshihide gastro-intestinal Clinic /ID# 256205 Ageo-shi Saitama
Japan Anjou Kousei Hospital /ID# 256207 Anjo-shi Aichi
Japan Asahi General Hospital /ID# 258446 Asahi-shi Chiba
Japan Atsugi Familly Clinic /ID# 259496 Atsugi-shi Kanagawa
Japan Juntendo University Hospital /ID# 259504 Bunkyo-ku Tokyo
Japan Chiba Clinic /ID# 257015 Chiba-shi Chiba
Japan Kobayashi Clinic /ID# 265631 Chikugo-shi Fukuoka
Japan Fukuoka University Chikushi Hospital /ID# 255248 Chikushino-shi Fukuoka
Japan Ginza Central Clinic /ID# 256208 Chuo-ku Tokyo
Japan Sai Gastroenterology and Proctology Clinic /ID# 252880 Fujidera-shi Osaka
Japan Sakemi clinic /ID# 261889 Fukuoka-shi Fukuoka
Japan NHO Fukuyama Medical Center /ID# 255246 Fukuyama-shi Hiroshima
Japan Gifu Municipal Hospital /ID# 255254 Gifu-shi Gifu
Japan Gifu University Hospital /ID# 258435 Gifu-shi Gifu
Japan Hachinohe City Hospital /ID# 256198 Hachinohe-shi
Japan Hamamatsu University Hospital /ID# 258438 Hamamatsu-shi Shizuoka
Japan Kashiwabara Gastroenterology Clinic /ID# 261885 Hamamatsu-shi Shizuoka
Japan Kato Clinic /ID# 254489 Hamamatsu-shi Shizuoka
Japan Hirakata Kohsai Hospital /ID# 256216 Hirakata Osaka
Japan Kansai Medical University Hospital /ID# 255247 Hirakata-shi Osaka
Japan Hiroshima University Hospital /ID# 257045 Hiroshima-shi Hiroshima
Japan Kaisei Clinic /ID# 258441 Hiroshima-shi Hiroshima
Japan Hitachinaka General Hospital /ID# 256209 Hitachinaka-shi Ibaraki
Japan Ichinomiyanishi Hospital /ID# 259498 Ichinomiya-shi Aichi
Japan Tokyo Medical University Ibaraki Medical Center /ID# 260210 Inashiki-shi Ibaraki
Japan Nippon Medical Chiba Hokusoh Hospital /ID# 259505 Inzai-shi Chiba
Japan Kagoshima IBD Gastroenterology Clinic /ID# 255191 Kagoshima-shi Kagoshima
Japan Sameshima Hospital /ID# 256215 Kagoshima-shi Kagoshima
Japan Gokeikai Ofuna Chuo Hospital /ID# 259502 Kamakura-shi Kanagawa
Japan Kanazawa Red Cross Hospital /ID# 262653 Kanazawa-shi Ishikawa
Japan Koyama Memorial Hospital /ID# 256212 Kashima City Ibaraki
Japan Tsujinaka Hospital Kashiwanoha /ID# 257013 Kashiwa-shi Chiba
Japan Shin-Yurigaoka General Hospital /ID# 265634 Kawasaki City Kanagawa
Japan Tobata Kyoritsu Hospital /ID# 257043 Kitakyusyu-shi Fukuoka
Japan Kobe University Hospital /ID# 260212 Kobe-shi Hyogo
Japan Nishi-Kobe Medical Center /ID# 258433 Kobe-shi Hyogo
Japan Iwamoto Naika Onaka Clinic /ID# 261888 Kofu-shi Yamanashi
Japan Koganei Tsurukame Clinic /ID# 260215 Koganei-shi Tokyo
Japan Showa Inan General Hospital /ID# 258413 Komagane-shi Nagano
Japan Hoshi General Hospital /ID# 261292 Koriyama City Fukushima
Japan Kumagaya General Hospital /ID# 261294 Kumagaya-shi Saitama
Japan Hattori Clinic /ID# 263978 Kumamoto
Japan Coloproctology Center Takano Hospital /ID# 257041 Kumamoto-shi Kumamoto
Japan Hidaka Clinic of Coloproctology /ID# 252879 Kurume-shi Fukuoka
Japan Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213 Kyoto-shi Kyoto
Japan National Hospital Organization Kyoto Medical Center /ID# 259497 Kyoto-shi Kyoto
Japan Matsuyama Red Cross Hospital /ID# 260211 Matsuyama-shi Ehime
Japan Dokkyo Medical University Hospital /ID# 257040 Mibu Tochigi
Japan Kitasato University Kitasato Institute Hospital /ID# 258434 Minato-ku Tokyo
Japan The Jikei University Hospital /ID# 262652 Minato-ku Tokyo
Japan Kyorin University - Mitaka Campus /ID# 261293 Mitaka
Japan Shinonoi General Hospital /ID# 261893 Nagano-shi Nagano
Japan Nagaoka Red Cross Hospital /ID# 255250 Nagaoka-shi Niigata
Japan Nagasaki Harbor Medical Center /ID# 264425 Nagasaki
Japan Aikawa Minnano-shinryojo /ID# 258447 Nagoya-shi Aichi
Japan Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049 Nagoya-shi Aichi
Japan Shimozato Clinic /ID# 261901 Nagoya-shi Aichi
Japan Naha City Hospital /ID# 255249 Naha Okinawa
Japan University of the Ryukyus Hospital /ID# 257044 Nakagami-gun Okinawa
Japan Nara Prefecture General Medical Center /ID# 256211 Nara-shi Nara
Japan Yoneyama Clinic /ID# 256210 Niigata-shi Niigata
Japan Hida Endoscopy Clinic /ID# 255252 Nishinomiya-shi Hyogo
Japan Hyogo Medical University Hospital /ID# 259500 Nishinomiya-shi Hyogo
Japan Yamada Coloproctology Clinic /ID# 259508 Niwa-gun Aichi
Japan Mori Surgical Clinic /ID# 258445 Ogaki-shi Gifu
Japan Ishida Clinic of IBD and Gastroenterology /ID# 252878 Oita-shi Oita
Japan Okayama University Hospital /ID# 262651 Okayama
Japan Nakagami Hospital /ID# 256214 Okinawa-shi Okinawa
Japan 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 Tane General Hospital /ID# 259495 Osaka-shi Osaka
Japan Yoshino Medical Clinic /ID# 255192 Osaka-shi Osaka
Japan Shiga University of Medical Science Hospital /ID# 258323 Otsu-shi Shiga
Japan Kitasato University Hospital /ID# 267442 Sagamihara Kanagawa
Japan Osaka Rosai Hospital /ID# 255244 Sakai-shi Osaka
Japan Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437 Sapporo-shi Hokkaido
Japan Sapporo IBD Clinic /ID# 255255 Sapporo-shi Hokkaido
Japan Chuno Kosei Hospital /ID# 263042 Seki City Gifu
Japan Tohoku Pharmaceutical University Hospital /ID# 265636 Sendai Miyagi
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 Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886 Shinjuku-ku Tokyo
Japan Keio University Hospital /ID# 261899 Shinjuku-ku Tokyo
Japan Tokyo Medical University Hospital /ID# 261291 Shinjuku-ku Tokyo
Japan Tokyo Women's Medical University Hospital /ID# 261887 Shinjuku-ku Tokyo
Japan Shizuoka Aoi Clinic /ID# 260219 Shizuoka-shi Shizuoka
Japan NHO Shizuoka Medical Center /ID# 260214 Sunto-gun Shizuoka
Japan Gifu Prefectural Tajimi Hosp /ID# 260213 Tajimi-shi Gifu
Japan Takamatsu Red Cross Hospital /ID# 259493 Takamatsu-shi Kagawa
Japan Kudo Gastroenterology Clinic /ID# 255251 Takasaki-shi Gunma
Japan St. Luke's International Hospital /ID# 264301 Tokyo
Japan Yokota Memorial Hospital /ID# 267044 Toyama-shi Toyama
Japan Toyonaka Municipal Hospital /ID# 258414 Toyonaka-shi Osaka
Japan Ieda Hospital /ID# 257012 Toyota-shi Aichi
Japan Mie University Hospital /ID# 257011 Tsu-shi Mie
Japan Tsuchiura Kyodo General Hospital /ID# 260732 Tsuchiura-shi Ibaraki
Japan Juntendo University Urayasu Hospital /ID# 265635 Urayasu Chiba
Japan Saiseikai Utsunomiya Hospital /ID# 254488 Utsunomiya-shi Tochigi
Japan Japanese Red Cross Wakayama Medical Center /ID# 255245 Wakayama-shi Wakayama
Japan Wakayama Medical University Hospital /ID# 259506 Wakayama-shi Wakayama
Japan Yamaguchi Red Cross Hospital /ID# 257016 Yamaguchi-shi Yamaguchi
Japan Yokkaichi Hazu Medical Center /ID# 257010 Yokkaichi-shi Mie
Japan Koganecho Sukoyaka Clinic /ID# 257014 Yokohama-shi Kanagawa
Japan Saiseikai Yokohamashi Tobu /ID# 261896 Yokohama-shi Kanagawa
Japan Yokohama Municipal Citizen's Hospital /ID# 259503 Yokohama-shi Kanagawa
Japan Yokohama Totsukaekimae Clinic /ID# 259509 Yokohama-shi Kanagawa

Sponsors (1)
Lead Sponsor Collaborator
AbbVie

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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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