An Observational Study to Assess Change in Disease Activity and Adverse Events in Adolescent and Adult Participants with Moderate to Severe Active Crohn's Disease (CD) in Japan

Last updated: February 26, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

N/A

Condition

Ulcerative Colitis

Bowel Dysfunction

Colic

Treatment

N/A

Clinical Study ID

NCT06023030
P24-080
  • Ages > 15
  • All Genders

Study Summary

Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective upadacitinib is in treating moderately to severely active CD in real world. Adverse events and change in disease activity will be assessed.

Upadacitinib is a drug approved for the treatment of CD. All study participants will receive upadacitinib as prescribed by their study doctor in accordance with approved local label. Approximately 240 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 64 weeks.

There is expected to be no additional burden for participants in this trial. Study visits may be conducted on-site or virtually as per standard of care.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed with moderately to severely active Crohn's disease (CD).

  • Has been prescribed upadacitinib for CD as per most current local approved labelafter its approval for CD in Japan.

  • Within 14 days from the commencement of upadacitinib induction treatment for CD atthe participating institution.

Exclusion

Exclusion Criteria:

  • Currently participating in another interventional clinical research.

  • Participants for whom upadacitinib is contraindicated.

  • Has been treated with upadacitinib for CD before and continue treatment withupadacitinib for CD at the participation to this study.

Study Design

Total Participants: 240
Study Start date:
July 28, 2023
Estimated Completion Date:
November 30, 2026

Connect with a study center

  • Anjou Kousei Hospital /ID# 261872

    Anjo-shi, Aichi 446-8602
    Japan

    Active - Recruiting

  • Handa City Hospital /ID# 270446

    Handa, Aichi 475-8599
    Japan

    Active - Recruiting

  • Aichi Medical University /ID# 261871

    Nagakute, Aichi 480-1195
    Japan

    Active - Recruiting

  • Aichi Medical University Hospital /ID# 261871

    Nagakute, Aichi 480-1195
    Japan

    Active - Recruiting

  • Aichi Medical University Hospital /ID# 261871

    Nagakute-shi, Aichi 480-1195
    Japan

    Site Not Available

  • Masuko Memorial Hospital /ID# 267420

    Nagoya, Aichi 453-0016
    Japan

    Active - Recruiting

  • Nagoya City University Hospital /ID# 275588

    Nagoya, Aichi 467-8602
    Japan

    Active - Recruiting

  • Toyohashi Municipal Hospital /ID# 274975

    Toyohashi, Aichi 441-8570
    Japan

    Active - Recruiting

  • Ieda Hospital /ID# 259754

    Toyota-shi, Aichi 470-1219
    Japan

    Active - Recruiting

  • Hachinohe City Hospital /ID# 264183

    Hachinohe, Aomori 031-0011
    Japan

    Active - Recruiting

  • Tsujinaka Hospital Kashiwanoha /ID# 262648

    Kashiwa-shi, Chiba 277-0871
    Japan

    Active - Recruiting

  • Japanese Red Cross Society Matsuyama Red Cross Hospital /ID# 266717

    Matsuyama, Ehime 7900826
    Japan

    Site Not Available

  • Matsuyama Red Cross Hospital /ID# 266717

    Matsuyama-shi, Ehime 790-8524
    Japan

    Active - Recruiting

  • Uwajima City Hospital /ID# 273444

    Uwajima, Ehime 798-0061
    Japan

    Active - Recruiting

  • Japanese Red Cross Society Matsuyama Red Cross Hospital /ID# 266717

    松山市, Ehime 79008
    Japan

    Site Not Available

  • National Hospital Organization Osaka Medical Center /ID# 264230

    Osaka, Fukui 540-0006
    Japan

    Site Not Available

  • Fukuoka University Chikushi Hospital /ID# 262686

    Chikushino-shi, Fukuoka 818-8502
    Japan

    Active - Recruiting

  • Steel Memorial Yahata Hospital /ID# 272713

    Kitakyushu, Fukuoka 805-0050
    Japan

    Active - Recruiting

  • Tobata Kyoritsu Hospital /ID# 273558

    Kitakyushu, Fukuoka 804-0093
    Japan

    Active - Recruiting

  • Hidaka Colon Proctology Clinic /ID# 268867

    Kurume, Fukuoka 839-0809
    Japan

    Active - Recruiting

  • Hakuai Clinic /ID# 261876

    Kurume-shi, Fukuoka 839-0863
    Japan

    Active - Recruiting

  • Southern Tohoku General Hospital /ID# 270447

    Koriyama, Fukushima 963-8563
    Japan

    Active - Recruiting

  • Sakura Clinic /ID# 268344

    Kakamigahara-shi, Gifu 504-0907
    Japan

    Active - Recruiting

  • NHO Fukuyama Medical Center /ID# 261873

    Fukuyama-shi, Hiroshima 720-8520
    Japan

    Active - Recruiting

  • JA Hiroshima General Hospital /ID# 264432

    Hatsukaichi, Hiroshima 738-8503
    Japan

    Active - Recruiting

  • Kaisei Clinic /ID# 261883

    Hiroshima-shi, Hiroshima 730-0017
    Japan

    Active - Recruiting

  • Ako-City Hospital /ID# 271276

    Ako, Hyogo 678-0232
    Japan

    Active - Recruiting

  • Himeji Chuo Hospital /ID# 272714

    Himeji, Hyogo 672-8501
    Japan

    Active - Recruiting

  • Aoyama Clinic /ID# 262658

    Kobe-shi, Hyogo 650-0015
    Japan

    Active - Recruiting

  • Kobe City Medical Center General Hospital /ID# 270950

    Kobe-shi, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Hyogo Medical University Hospital /ID# 267383

    Nishinomiya, Hyogo 663-8501
    Japan

    Active - Recruiting

  • Hyogo Prefectural Harima-Himeji General Medical Center /ID# 274528

    姫路市, Hyogo 670-0836
    Japan

    Active - Recruiting

  • Tsukuba Endoscopy clinic /ID# 261880

    Tsukuba-shi, Ibaraki 305-0821
    Japan

    Active - Recruiting

  • National Hospital Organization Kanazawa Medical Center /ID# 268820

    Kanazawa, Ishikawa 920-8650
    Japan

    Active - Recruiting

  • Takamatsu Red Cross Hospital /ID# 268823

    Takamatsu, Kagawa 760-0017
    Japan

    Active - Recruiting

  • Tokai University Hospital /ID# 270949

    Isehara, Kanagawa 259-1193
    Japan

    Active - Recruiting

  • Gokeikai Ofuna Chuo Hospital /ID# 262649

    Kamakura-shi, Kanagawa 247-0056
    Japan

    Active - Recruiting

  • Inoue Gastroenterology Clinic /ID# 275555

    Yokohama, Kanagawa 223-0053
    Japan

    Active - Recruiting

  • Saiseikai Yokohama Tobu Hospital /ID# 264186

    Yokohama, Kanagawa 230-0012
    Japan

    Active - Recruiting

  • Yokohama Municipal Citizen's Hospital /ID# 267375

    Yokohama, Kanagawa 221-0855
    Japan

    Active - Recruiting

  • Yokohama Municipal Citizen's Hospital /ID# 267375

    Yokohama-shi, Kanagawa 221-0855
    Japan

    Active - Recruiting

  • Chikamori Hospital /ID# 267382

    Kochi City, Kochi 780-8522
    Japan

    Active - Recruiting

  • Coloproctology Center Takano Hospital /ID# 268868

    Kumamoto-shi, Kumamoto 862-0971
    Japan

    Active - Recruiting

  • Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660

    Kyoto-shi, Kyoto 605-0981
    Japan

    Active - Recruiting

  • National Hospital Organization Kyoto Medical Center /ID# 265461

    Kyoto-shi, Kyoto 612-8555
    Japan

    Active - Recruiting

  • Mie University Hospital /ID# 262656

    Tsu-shi, Mie 514-8507
    Japan

    Active - Recruiting

  • Yokkaichi Hazu Medical Center /ID# 260140

    Yokkaichi-shi, Mie 510-0016
    Japan

    Active - Recruiting

  • Nagano Municipal Hospital /ID# 262627

    Nagano-shi, Nagano 3818551
    Japan

    Active - Recruiting

  • Ishida Clinic of IBD and Gastroenterology /ID# 261884

    Oita-shi, Oita 870-0823
    Japan

    Active - Recruiting

  • University of the Ryukyus Hospital /ID# 264430

    Ginowan-shi, Okinawa 901-2725
    Japan

    Active - Recruiting

  • Naha City Hospital /ID# 261875

    Naha, Okinawa 902-0061
    Japan

    Active - Recruiting

  • Naha City Hospital /ID# 261875

    Naha-shi, Okinawa 902-8511
    Japan

    Site Not Available

  • University of the Ryukyus Hospital /ID# 264430

    Nishihara, Okinawa 903-0215
    Japan

    Site Not Available

  • Seshimo Gastroy & Procto Clinic /ID# 271658

    Ibaraki-shi, Osaka 567-0882
    Japan

    Active - Recruiting

  • Moriguchi Keijinkai Hospital /ID# 268821

    Moriguchi City, Osaka 570-0013
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital /ID# 273559

    Osaka-City, Osaka 545-8586
    Japan

    Site Not Available

  • Kinshukai Infusion Clinic /ID# 261332

    Osaka-shi, Osaka 530-0011
    Japan

    Active - Recruiting

  • National Hospital Organization Osaka National Hospital /ID# 264230

    Osaka-shi, Osaka 540-0006
    Japan

    Active - Recruiting

  • Osaka Metropolitan University Hospital /ID# 273559

    Osaka-shi, Osaka 545-8586
    Japan

    Active - Recruiting

  • Tane General Hospital /ID# 268871

    Osaka-shi, Osaka 550-0025
    Japan

    Active - Recruiting

  • Osaka Rosai Hospital /ID# 267379

    Sakai City, Osaka 591-8025
    Japan

    Active - Recruiting

  • Fujita Gastroenterology Hospital /ID# 275410

    Takatsuki, Osaka 569-0086
    Japan

    Active - Recruiting

  • Saitama Medical Center /ID# 270948

    Kawagoe, Saitama 350-8550
    Japan

    Active - Recruiting

  • Tokitokai Tokito clinic /ID# 262661

    Saitama-shi, Saitama 336-0963
    Japan

    Active - Recruiting

  • Tokorozawa Proctogic Hospital /ID# 268870

    Tokorozawa, Saitama 359-1141
    Japan

    Active - Recruiting

  • Kato Clinic /ID# 262650

    Hamamatsu-shi, Shizuoka 432-8061
    Japan

    Active - Recruiting

  • Shizuoka Medical Center /ID# 275551

    Shimizu, Shizuoka 411-0905
    Japan

    Active - Recruiting

  • Shizuoka Aoi Clinic /ID# 267376

    Shizuoka-shi, Shizuoka 420-0881
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 266710

    Mibu, Tochigi 321-0293
    Japan

    Active - Recruiting

  • Dokkyo Medical University Hospital /ID# 266710

    Shimotsuga-gun, Tochigi 321-0293
    Japan

    Site Not Available

  • Saiseikai Utsunomiya Hospital /ID# 261878

    Utsunomiya-shi, Tochigi 321-0974
    Japan

    Active - Recruiting

  • Juntendo University Hospital /ID# 265452

    Bunkyo-ku, Tokyo 113-8431
    Japan

    Active - Recruiting

  • Ginza Central Clinic /ID# 261881

    Chuo-ku, Tokyo 104-0061
    Japan

    Active - Recruiting

  • Koganei Tsurukame Clinic /ID# 271660

    Koganei-shi, Tokyo 184-0004
    Japan

    Active - Recruiting

  • Ohori IBD Clinic /ID# 261882

    Setagaya-ku, Tokyo 155-0032
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital /ID# 262683

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Active - Recruiting

  • Tokyo Women'S Medical University Hospital /ID# 274527

    Shinjuku-ku, Tokyo 162-8666
    Japan

    Active - Recruiting

  • The Fraternity Memorial Hospital /ID# 274976

    Sumida-ku, Tokyo 1308587
    Japan

    Active - Recruiting

  • Yokota Memorial Hospital /ID# 266714

    Toyama-shi, Toyama 939-8085
    Japan

    Active - Recruiting

  • Wakayama Medical University Hospital /ID# 262685

    Wakayama-shi, Wakayama 641-8510
    Japan

    Active - Recruiting

  • Sentohill Hospital /ID# 268869

    Ube, Yamaguchi 755-0155
    Japan

    Active - Recruiting

  • Yamanashi Prefectural Central Hospital /ID# 274526

    Kofu, Yamanashi 400-0027
    Japan

    Active - Recruiting

  • Fukuiken Saiseikai Hospital /ID# 274835

    Fukui, 918-8235
    Japan

    Active - Recruiting

  • Fukushima Red Cross Hospital /ID# 275322

    Fukushima, 960-8530
    Japan

    Active - Recruiting

  • Gifu University Hospital /ID# 266711

    Gifu, 501-1112
    Japan

    Active - Recruiting

  • Kagoshima IBD Gastroenterology Clinic /ID# 265505

    Kagoshima, 892-0843
    Japan

    Active - Recruiting

  • Kuniyoshi Hospital /ID# 271878

    Kochi, 780-0901
    Japan

    Active - Recruiting

  • National Hospital Organization Kyoto Medical Center /ID# 265461

    Kyoto, 612-8555
    Japan

    Site Not Available

  • Saitama City Hospital /ID# 266716

    Saitama, 336-8522
    Japan

    Active - Recruiting

  • Sapporo Kosei General Hospital /ID# 267374

    Sapporo, 060-0033
    Japan

    Active - Recruiting

  • Juntendo University Hospital /ID# 265452

    Tokyo, 113-0033
    Japan

    Active - Recruiting

  • Kitasato University Kitasato Institute Hospital /ID# 268345

    Tokyo, 108-8642
    Japan

    Active - Recruiting

  • Teikyo University Hospital /ID# 274525

    Tokyo, 173-8605
    Japan

    Active - Recruiting

  • Teikyo University Hospital /ID# 274977

    Tokyo, 173-8605
    Japan

    Active - Recruiting

  • Tokyo Yamate Medical Center /ID# 275591

    Tokyo, 169-0073
    Japan

    Active - Recruiting

  • Municipal Toyonaka Hospital /ID# 266712

    Toyonaka, 560-0055
    Japan

    Active - Recruiting

  • Japanese Red Cross Society - Wakayama Medical Center /ID# 268822

    Wakayama, 640-8558
    Japan

    Active - Recruiting

  • Yamagata Prefectural Central Hospital - Yamagata /ID# 268819

    Yamagata, 990-2292
    Japan

    Active - Recruiting

  • Yamaguchi Red Cross Hospital /ID# 267381

    Yamaguchi, 753-8519
    Japan

    Active - Recruiting

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