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

NCT ID: NCT05791526

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 308 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-12-19
• Study Completion Date: 2025-12-09

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.

Conditions

Ulcerative Colitis

Keywords

Ulcerative colitis; UC; Rinvoq; Upadacitinib

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Participants Receiving Upadacitinib

Participants receiving upadacitinib for moderate to severe Ulcerative colitis (UC) in real-world practice.

No interventions assigned to this group

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

Anjou Kousei Hospital /ID# 256207

Anjo-shi, Aichi-ken, Japan

Ichinomiyanishi Hospital /ID# 259498

Ichinomiya-shi, Aichi-ken, Japan

Aikawa Minnano-shinryojo /ID# 258447

Nagoya, Aichi-ken, Japan

Shimozato Clinic /ID# 261901

Nagoya, Aichi-ken, Japan

Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049

Nagoya, Aichi-ken, Japan

Yamada Coloproctology Clinic /ID# 259508

Niwa-gun, Aichi-ken, Japan

Toyohashi Municipal Hospital /ID# 267048

Toyohashi, Aichi-ken, Japan

Ieda Hospital /ID# 257012

Toyota-shi, Aichi-ken, Japan

Hachinohe City Hospital /ID# 256198

Hachinohe-shi, Aomori, Japan

Asahi General Hospital /ID# 258446

Asahi, Chiba, Japan

Chiba Clinic /ID# 257015

Chiba, Chiba, Japan

Nippon Medical Chiba Hokusoh Hospital /ID# 259505

Inzai-shi, Chiba, Japan

Tsujinaka Hospital - Kashiwanoha /ID# 257013

Kashiwa-shi, Chiba, Japan

Juntendo University Urayasu Hospital /ID# 265635

Urayasu, Chiba, Japan

Matsuyama Red Cross Hospital /ID# 260211

Matsuyama, Ehime, Japan

Kobayashi Clinic /ID# 265631

Chikugo-shi, Fukuoka, Japan

Fukuoka University Chikushi Hospital /ID# 255248

Chikushino-shi, Fukuoka, Japan

Sakemi clinic /ID# 261889

Fukuoka, Fukuoka, Japan

Tobata Kyoritsu Hospital /ID# 257043

Kitakyusyu-shi, Fukuoka, Japan

Hidaka Clinic of Coloproctology /ID# 252879

Kurume-shi, Fukuoka, Japan

Hoshi General Hospital /ID# 261292

Koriyama-shi, Fukushima, Japan

Southern Tohoku General Hospital /ID# 267043

Kōriyama, Fukushima, Japan

Fukutomi Icyo Clinic /ID# 267047

Gifu, Gifu, Japan

Gifu Municipal Hospital /ID# 255254

Gifu, Gifu, Japan

Gifu University Hospital /ID# 258435

Gifu, Gifu, Japan

Mori Surgical Clinic /ID# 258445

Ogaki-shi, Gifu, Japan

Chuno Kosei Hospital /ID# 263042

Seki-shi, Gifu, Japan

Gifu Prefectural Tajimi Hosp /ID# 260213

Tajimi-shi, Gifu, Japan

Kudo Gastroenterology Clinic /ID# 255251

Takasaki-shi, Gunma, Japan

National Hospital Organization Fukuyama Medical Center /ID# 255246

Fukuyama-shi, Hiroshima, Japan

Kaisei Clinic /ID# 258441

Hiroshima, Hiroshima, Japan

Hiroshima University Hospital /ID# 257045

Hiroshima, Hiroshima, Japan

Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 258437

Sapporo, Hokkaido, Japan

Sapporo IBD Clinic /ID# 255255

Sapporo, Hokkaido, Japan

Kobe University Hospital /ID# 260212

Kobe, Hyōgo, Japan

Nishi-Kobe Medical Center /ID# 258433

Kobe, Hyōgo, Japan

Hida Endoscopy Clinic /ID# 255252

Nishinomiya-shi, Hyōgo, Japan

Hyogo Medical University Hospital /ID# 259500

Nishinomiya-shi, Hyōgo, Japan

Hitachinaka General Hospital /ID# 256209

Hitachi-Naka, Ibaraki, Japan

Tokyo Medical University Ibaraki Medical Center /ID# 260210

Inashiki-shi, Ibaraki, Japan

Koyama Memorial Hospital /ID# 256212

Kashima-shi, Ibaraki, Japan

Tsuchiura Kyodo General Hospital /ID# 260732

Tsuchiura-shi, Ibaraki, Japan

Kanazawa Red Cross Hospital /ID# 262653

Kanazawa, Ishikawa-ken, Japan

Takamatsu Red Cross Hospital /ID# 259493

Takamatsu, Kagawa-ken, Japan

Sameshima Hospital /ID# 256215

Kagoshima, Kagoshima-ken, Japan

Kagoshima IBD Gastroenterology Clinic /ID# 255191

Kagoshima, Kagoshima-ken, Japan

Atsugi Familly Clinic /ID# 259496

Atsugi-shi, Kanagawa, Japan

Gokeikai Ofuna Chuo Hospital /ID# 259502

Kamakura-shi, Kanagawa, Japan

Shin-Yurigaoka General Hospital /ID# 265634

Kawasaki-shi, Kanagawa, Japan

Kitasato University Hospital /ID# 267442

Sagamihara-shi, Kanagawa, Japan

Yokohama Municipal Citizen's Hospital /ID# 259503

Yokohama, Kanagawa, Japan

Saiseikai Yokohamashi Tobu /ID# 261896

Yokohama, Kanagawa, Japan

Koganecho Sukoyaka Clinic /ID# 257014

Yokohama, Kanagawa, Japan

Yokohama Totsukaekimae Clinic /ID# 259509

Yokohama, Kanagawa, Japan

Coloproctology Center Takano Hospital /ID# 257041

Kumamoto, Kumamoto, Japan

Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213

Kyoto, Kyoto, Japan

National Hospital Organization Kyoto Medical Center /ID# 259497

Kyoto, Kyoto, Japan

Mie University Hospital /ID# 257011

Tsu, Mie-ken, Japan

Yokkaichi Hazu Medical Center /ID# 257010

Yokkaichi-shi, Mie-ken, Japan

Tohoku Medical and Pharmaceutical University Hospital /ID# 265636

Sendai, Miyagi, Japan

Showa Inan General Hospital /ID# 258413

Komagane-shi, Nagano, Japan

Shinonoi General Hospital /ID# 261893

Nagano, Nagano, Japan

Nara Prefecture General Medical Center - Nara /ID# 256211

Nara, Nara, Japan

Nagaoka Red Cross Hospital /ID# 255250

Nagaoka-shi, Niigata, Japan

Yoneyama Clinic /ID# 256210

Niigata, Niigata, Japan

Ishida Clinic of IBD and Gastroenterology /ID# 252878

Ōita, Oita Prefecture, Japan

Okayama University Hospital /ID# 262651

Okayama, Okayama-ken, Japan

University of the Ryukyus Hospital /ID# 257044

Ginowan-shi, Okinawa, Japan

Naha City Hospital /ID# 255249

Naha, Okinawa, Japan

Nakagami Hospital /ID# 256214

Okinawa-shi, Okinawa, Japan

Urasoe General Hospital /ID# 267042

Urasoe, Okinawa, Japan

Sai Gastroenterology and Proctology Clinic /ID# 252880

Fujidera-shi, Osaka, Japan

Hirakata Kohsai Hospital /ID# 256216

Hirakata, Osaka, Japan

Kansai Medical University Hospital /ID# 255247

Hirakata-shi, Osaka, Japan

Kinshukai Infusion Clinic /ID# 253199

Osaka, Osaka, Japan

National Hospital Organization Osaka National Hospital /ID# 257042

Osaka, Osaka, Japan

Osaka Metropolitan University Hospital /ID# 258319

Osaka, Osaka, Japan

Tane General Hospital /ID# 259495

Osaka, Osaka, Japan

Yoshino Medical Clinic /ID# 255192

Osaka, Osaka, Japan

Osaka Rosai Hospital /ID# 255244

Sakai-shi, Osaka, Japan

Toyonaka Municipal Hospital /ID# 258414

Toyonaka-shi, Osaka, Japan

Ohmori Toshihide gastro-intestinal Clinic /ID# 256205

Ageo-shi, Saitama, Japan

Kumagaya General Hospital /ID# 261294

Kumagaya-shi, Saitama, Japan

Shiga University of Medical Science Hospital /ID# 258323

Ōtsu, Shiga, Japan

Hamamatsu University Hospital /ID# 258438

Hamamatsu, Shizuoka, Japan

Kato Clinic /ID# 254489

Hamamatsu, Shizuoka, Japan

Kashiwabara Gastroenterology Clinic /ID# 261885

Hamamatsu, Shizuoka, Japan

Shizuoka Aoi Clinic /ID# 260219

Shizuoka, Shizuoka, Japan

NHO Shizuoka Medical Center /ID# 260214

Sunto-gun, Shizuoka, Japan

Dokkyo Medical University Hospital /ID# 257040

Mibu, Tochigi, Japan

Saiseikai Utsunomiya Hospital /ID# 254488

Utsunomiya, Tochigi, Japan

Juntendo University Hospital /ID# 259504

Bunkyo-ku, Tokyo, Japan

Ginza Central Clinic /ID# 256208

Chuo-ku, Tokyo, Japan

Koganei Tsurukame Clinic /ID# 260215

Koganei-shi, Tokyo, Japan

Kitasato University Kitasato Institute Hospital /ID# 258434

Minato-ku, Tokyo, Japan

Kyorin University Hospital /ID# 261293

Mitaka-shi, Tokyo, 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

Tokyo Medical University Hospital /ID# 261291

Shinjuku-ku, Tokyo, Japan

Keio University Hospital /ID# 261899

Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital /ID# 261887

Shinjuku-ku, Tokyo, Japan

Japan Community Health care Organization Tokyo Yamate Medical Center /ID# 261886

Shinjuku-ku, Tokyo, Japan

Tottori University Hospital /ID# 265633

Yonago, Tottori, Japan

Yokota Memorial Hospital /ID# 267044

Toyama, Toyama, Japan

Japanese Red Cross Wakayama Medical Center /ID# 255245

Wakayama, Wakayama, Japan

Wakayama Medical University Hospital /ID# 259506

Wakayama, Wakayama, Japan

Yamaguchi Red Cross Hospital /ID# 257016

Yamaguchi, Yamaguchi, Japan

Iwamoto Naika Onaka Clinic /ID# 261888

Kofu, Yamanashi, Japan

Aomori Prefectural Central Hospital /ID# 266719

Aomori, , Japan

Hattori Clinic - Kumamoto /ID# 263978

Kumamoto, , Japan

Nagasaki Harbor Medical Center /ID# 264425

Nagasaki, , Japan

St. Luke's International Hospital /ID# 264301

Tokyo, , Japan

The Jikei University Hospital /ID# 262652

Tokyo, , Japan

Countries

Japan

Related Links

https://www.abbvieclinicaltrials.com/study/?id=P22-962

Related info

Other Identifiers

P22-962

Identifier Type: -

Identifier Source: org_study_id