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

Last updated: July 15, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Inflammatory Bowel Disease

Crohn's Disease

Treatment

N/A

Clinical Study ID

NCT05791526
P22-962
  • Ages > 15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants diagnosed with moderately to severely active Ulcerative colitis (UC).

  • Participants who are within 14 days from the commencement of Rinvoq treatment forUC.

  • Participants who are administered the first dose of Rinvoq for UC after approval forUC in Japan.

Exclusion

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

Total Participants: 300
Study Start date:
December 19, 2022
Estimated Completion Date:
November 30, 2025

Connect with a study center

  • Anjou Kousei Hospital /ID# 256207

    Anjo-shi, Aichi 446-8602
    Japan

    Active - Recruiting

  • Ichinomiyanishi Hospital /ID# 259498

    Ichinomiya-shi, Aichi 494-0001
    Japan

    Active - Recruiting

  • Aikawa Minnano-shinryojo /ID# 258447

    Nagoya-shi, Aichi 458-0011
    Japan

    Active - Recruiting

  • Miwa Internist and Gastroenterology Clinic Aoi /ID# 267049

    Nagoya-shi, Aichi 461-0004
    Japan

    Active - Recruiting

  • Shimozato Clinic /ID# 261901

    Nagoya-shi, Aichi 458-0044
    Japan

    Active - Recruiting

  • Yamada Coloproctology Clinic /ID# 259508

    Niwa-gun, Aichi 480-0147
    Japan

    Active - Recruiting

  • Ieda Hospital /ID# 257012

    Toyota-shi, Aichi 470-1219
    Japan

    Active - Recruiting

  • Asahi General Hospital /ID# 258446

    Asahi-shi, Chiba 289-2511
    Japan

    Active - Recruiting

  • Chiba Clinic /ID# 257015

    Chiba-shi, Chiba 260-0018
    Japan

    Active - Recruiting

  • Nippon Medical Chiba Hokusoh Hospital /ID# 259505

    Inzai-shi, Chiba 270-1613
    Japan

    Active - Recruiting

  • Tsujinaka Hospital Kashiwanoha /ID# 257013

    Kashiwa-shi, Chiba 277-0871
    Japan

    Active - Recruiting

  • Juntendo University Urayasu Hospital /ID# 265635

    Urayasu, Chiba 279-0021
    Japan

    Active - Recruiting

  • Matsuyama Red Cross Hospital /ID# 260211

    Matsuyama-shi, Ehime 790-8524
    Japan

    Active - Recruiting

  • Kobayashi Clinic /ID# 265631

    Chikugo-shi, Fukuoka 833-0005
    Japan

    Active - Recruiting

  • Fukuoka University Chikushi Hospital /ID# 255248

    Chikushino-shi, Fukuoka 818-8502
    Japan

    Active - Recruiting

  • Sakemi clinic /ID# 261889

    Fukuoka-shi, Fukuoka 813-0003
    Japan

    Active - Recruiting

  • Tobata Kyoritsu Hospital /ID# 257043

    Kitakyusyu-shi, Fukuoka 803-0836
    Japan

    Active - Recruiting

  • Hidaka Clinic of Coloproctology /ID# 252879

    Kurume-shi, Fukuoka 839-0809
    Japan

    Active - Recruiting

  • Hoshi General Hospital /ID# 261292

    Koriyama City, Fukushima 963-8801
    Japan

    Active - Recruiting

  • Gifu Municipal Hospital /ID# 255254

    Gifu-shi, Gifu 500-8513
    Japan

    Active - Recruiting

  • Gifu University Hospital /ID# 258435

    Gifu-shi, Gifu 501-1194
    Japan

    Active - Recruiting

  • Mori Surgical Clinic /ID# 258445

    Ogaki-shi, Gifu 503-0031
    Japan

    Active - Recruiting

  • Chuno Kosei Hospital /ID# 263042

    Seki City, Gifu 501-3802
    Japan

    Active - Recruiting

  • Gifu Prefectural Tajimi Hosp /ID# 260213

    Tajimi-shi, Gifu 507-8522
    Japan

    Active - Recruiting

  • Kudo Gastroenterology Clinic /ID# 255251

    Takasaki-shi, Gunma 370-0848
    Japan

    Active - Recruiting

  • NHO Fukuyama Medical Center /ID# 255246

    Fukuyama-shi, Hiroshima 720-8520
    Japan

    Active - Recruiting

  • Hiroshima University Hospital /ID# 257045

    Hiroshima-shi, Hiroshima 734-8551
    Japan

    Active - Recruiting

  • Kaisei Clinic /ID# 258441

    Hiroshima-shi, Hiroshima 730-0017
    Japan

    Active - Recruiting

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

    Sapporo-shi, Hokkaido 060-0033
    Japan

    Active - Recruiting

  • Sapporo IBD Clinic /ID# 255255

    Sapporo-shi, Hokkaido 064-0919
    Japan

    Active - Recruiting

  • Kobe University Hospital /ID# 260212

    Kobe-shi, Hyogo 650-0017
    Japan

    Active - Recruiting

  • Nishi-Kobe Medical Center /ID# 258433

    Kobe-shi, Hyogo 651-2273
    Japan

    Active - Recruiting

  • Hida Endoscopy Clinic /ID# 255252

    Nishinomiya-shi, Hyogo 662-0973
    Japan

    Active - Recruiting

  • Hyogo Medical University Hospital /ID# 259500

    Nishinomiya-shi, Hyogo 663-8501
    Japan

    Active - Recruiting

  • Hitachinaka General Hospital /ID# 256209

    Hitachinaka-shi, Ibaraki 312-0057
    Japan

    Active - Recruiting

  • Tokyo Medical University Ibaraki Medical Center /ID# 260210

    Inashiki-shi, Ibaraki 300-0332
    Japan

    Active - Recruiting

  • Koyama Memorial Hospital /ID# 256212

    Kashima City, Ibaraki 314-0030
    Japan

    Active - Recruiting

  • Tsuchiura Kyodo General Hospital /ID# 260732

    Tsuchiura-shi, Ibaraki 300-0053
    Japan

    Active - Recruiting

  • Kanazawa Red Cross Hospital /ID# 262653

    Kanazawa-shi, Ishikawa 921-8162
    Japan

    Active - Recruiting

  • Takamatsu Red Cross Hospital /ID# 259493

    Takamatsu-shi, Kagawa 760-0017
    Japan

    Active - Recruiting

  • Kagoshima IBD Gastroenterology Clinic /ID# 255191

    Kagoshima-shi, Kagoshima 8920804
    Japan

    Active - Recruiting

  • Sameshima Hospital /ID# 256215

    Kagoshima-shi, Kagoshima 892-0846
    Japan

    Active - Recruiting

  • Atsugi Familly Clinic /ID# 259496

    Atsugi-shi, Kanagawa 243-0018
    Japan

    Active - Recruiting

  • Gokeikai Ofuna Chuo Hospital /ID# 259502

    Kamakura-shi, Kanagawa 247-0056
    Japan

    Active - Recruiting

  • Shin-Yurigaoka General Hospital /ID# 265634

    Kawasaki City, Kanagawa 2150026
    Japan

    Active - Recruiting

  • Kitasato University Hospital /ID# 267442

    Sagamihara, Kanagawa 252-0375
    Japan

    Active - Recruiting

  • Koganecho Sukoyaka Clinic /ID# 257014

    Yokohama-shi, Kanagawa 232-0003
    Japan

    Active - Recruiting

  • Saiseikai Yokohamashi Tobu /ID# 261896

    Yokohama-shi, Kanagawa 230-0012
    Japan

    Active - Recruiting

  • Yokohama Municipal Citizen's Hospital /ID# 259503

    Yokohama-shi, Kanagawa 221-0855
    Japan

    Active - Recruiting

  • Yokohama Totsukaekimae Clinic /ID# 259509

    Yokohama-shi, Kanagawa 244-0003
    Japan

    Active - Recruiting

  • Coloproctology Center Takano Hospital /ID# 257041

    Kumamoto-shi, Kumamoto 862-0971
    Japan

    Active - Recruiting

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 256213

    Kyoto-shi, Kyoto 605-0981
    Japan

    Active - Recruiting

  • National Hospital Organization Kyoto Medical Center /ID# 259497

    Kyoto-shi, Kyoto 612-8555
    Japan

    Active - Recruiting

  • Mie University Hospital /ID# 257011

    Tsu-shi, Mie 514-8507
    Japan

    Active - Recruiting

  • Yokkaichi Hazu Medical Center /ID# 257010

    Yokkaichi-shi, Mie 510-0016
    Japan

    Active - Recruiting

  • Tohoku Pharmaceutical University Hospital /ID# 265636

    Sendai, Miyagi 983-0005
    Japan

    Active - Recruiting

  • Showa Inan General Hospital /ID# 258413

    Komagane-shi, Nagano 3994117
    Japan

    Active - Recruiting

  • Shinonoi General Hospital /ID# 261893

    Nagano-shi, Nagano 388-8004
    Japan

    Active - Recruiting

  • Nara Prefecture General Medical Center /ID# 256211

    Nara-shi, Nara 630-8054
    Japan

    Active - Recruiting

  • Nagaoka Red Cross Hospital /ID# 255250

    Nagaoka-shi, Niigata 940-2085
    Japan

    Active - Recruiting

  • Yoneyama Clinic /ID# 256210

    Niigata-shi, Niigata 950-2028
    Japan

    Active - Recruiting

  • Ishida Clinic of IBD and Gastroenterology /ID# 252878

    Oita-shi, Oita 870-0823
    Japan

    Active - Recruiting

  • Okayama University Hospital /ID# 262651

    Okayama-shi, Okayama 700-8558
    Japan

    Site Not Available

  • Naha City Hospital /ID# 255249

    Naha, Okinawa 902-0061
    Japan

    Active - Recruiting

  • Naha City Hospital /ID# 255249

    Naha-shi, Okinawa 902-8511
    Japan

    Site Not Available

  • University of the Ryukyus Hospital /ID# 257044

    Nakagami-gun, Okinawa 903-0215
    Japan

    Active - Recruiting

  • Nakagami Hospital /ID# 256214

    Okinawa-shi, Okinawa 904-2195
    Japan

    Active - Recruiting

  • Sai Gastroenterology and Proct /ID# 252880

    Fujidera-shi, Osaka 583-0035
    Japan

    Active - Recruiting

  • Sai Gastroenterology and Proctology Clinic /ID# 252880

    Fujidera-shi, Osaka 583-0027
    Japan

    Active - Recruiting

  • Hirakata Kohsai Hospital /ID# 256216

    Hirakata, Osaka 573-0153
    Japan

    Active - Recruiting

  • Kansai Medical University Hospital /ID# 255247

    Hirakata-shi, Osaka 573-1191
    Japan

    Active - Recruiting

  • Kinshukai Infusion Clinic /ID# 253199

    Osaka-shi, Osaka 530-0011
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka National Hospital /ID# 257042

    Osaka-shi, Osaka 540-0006
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital /ID# 258319

    Osaka-shi, Osaka 545-8586
    Japan

    Active - Recruiting

  • Tane General Hospital /ID# 259495

    Osaka-shi, Osaka 550-0025
    Japan

    Active - Recruiting

  • Yoshino Medical Clinic /ID# 255192

    Osaka-shi, Osaka 553-0002
    Japan

    Active - Recruiting

  • Osaka Rosai Hospital /ID# 255244

    Sakai-shi, Osaka 591-8025
    Japan

    Active - Recruiting

  • Toyonaka Municipal Hospital /ID# 258414

    Toyonaka-shi, Osaka 560-0055
    Japan

    Active - Recruiting

  • Ohmori Toshihide gastro-intestinal Clinic /ID# 256205

    Ageo-shi, Saitama 362-0075
    Japan

    Active - Recruiting

  • Kumagaya General Hospital /ID# 261294

    Kumagaya-shi, Saitama 331-0074
    Japan

    Active - Recruiting

  • Shiga University of Medical Science Hospital /ID# 258323

    Otsu-shi, Shiga 520-2192
    Japan

    Active - Recruiting

  • Hamamatsu University Hospital /ID# 258438

    Hamamatsu-shi, Shizuoka 431-3192
    Japan

    Active - Recruiting

  • Kashiwabara Gastroenterology Clinic /ID# 261885

    Hamamatsu-shi, Shizuoka 433-8113
    Japan

    Active - Recruiting

  • Kato Clinic /ID# 254489

    Hamamatsu-shi, Shizuoka 432-8061
    Japan

    Active - Recruiting

  • Shizuoka Aoi Clinic /ID# 260219

    Shizuoka-shi, Shizuoka 420-0881
    Japan

    Active - Recruiting

  • NHO Shizuoka Medical Center /ID# 260214

    Sunto-gun, Shizuoka 411-8611
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 257040

    Mibu, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 257040

    Shimotsuga-gun, Tochigi 321-0293
    Japan

    Site Not Available

  • Saiseikai Utsunomiya Hospital /ID# 254488

    Utsunomiya-shi, Tochigi 321-0974
    Japan

    Active - Recruiting

  • Juntendo University Hospital /ID# 259504

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Ginza Central Clinic /ID# 256208

    Chuo-ku, Tokyo 104-0061
    Japan

    Active - Recruiting

  • Koganei Tsurukame Clinic /ID# 260215

    Koganei-shi, Tokyo 184-0004
    Japan

    Active - Recruiting

  • Kitasato University Kitasato Institute Hospital /ID# 258434

    Minato-ku, Tokyo 108-8642
    Japan

    Active - Recruiting

  • The Jikei University Hospital /ID# 262652

    Minato-ku, Tokyo 105-8471
    Japan

    Active - Recruiting

  • Kyorin University Hospital /ID# 261293

    Mitaka-shi, Tokyo 181-8611
    Japan

    Site Not Available

  • Ohori IBD Clinic /ID# 255253

    Setagaya-ku, Tokyo 155-0032
    Japan

    Active - Recruiting

  • Shinjuku Tsurukame Clinic /ID# 258443

    Shibuya-ku, Tokyo 151-0053
    Japan

    Active - Recruiting

  • Showa University Hospital /ID# 261898

    Shinagawa-ku, Tokyo 142-8666
    Japan

    Active - Recruiting

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

    Shinjuku-ku, Tokyo 169-0073
    Japan

    Active - Recruiting

  • Keio University Hospital /ID# 261899

    Shinjuku-ku, Tokyo 160-8582
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital /ID# 261291

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Tokyo Women's Medical University Hospital /ID# 261887

    Shinjuku-ku, Tokyo 162-8666
    Japan

    Active - Recruiting

  • Yokota Memorial Hospital /ID# 267044

    Toyama-shi, Toyama 939-8085
    Japan

    Active - Recruiting

  • Japanese Red Cross Wakayama Medical Center /ID# 255245

    Wakayama-shi, Wakayama 640-8558
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital /ID# 259506

    Wakayama-shi, Wakayama 641-8510
    Japan

    Active - Recruiting

  • Yamaguchi Red Cross Hospital /ID# 257016

    Yamaguchi-shi, Yamaguchi 753-8519
    Japan

    Active - Recruiting

  • Iwamoto Naika Onaka Clinic /ID# 261888

    Kofu-shi, Yamanashi 400-0813
    Japan

    Active - Recruiting

  • Hachinohe City Hospital /ID# 256198

    Hachinohe-shi, 031-8555
    Japan

    Active - Recruiting

  • Hattori Clinic /ID# 263978

    Kumamoto, 860-0004
    Japan

    Active - Recruiting

  • Kyorin University - Mitaka Campus /ID# 261293

    Mitaka, 181-8611
    Japan

    Active - Recruiting

  • Nagasaki Harbor Medical Center /ID# 264425

    Nagasaki, 850-0842
    Japan

    Active - Recruiting

  • Okayama University Hospital /ID# 262651

    Okayama, 700-8558
    Japan

    Active - Recruiting

  • St. Luke's International Hospital /ID# 264301

    Tokyo, 104-8560
    Japan

    Active - Recruiting

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