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

February 23, 2026 updated by: AbbVie

A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

240

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Japan
      • Fukui, Japan, 918-8235
        • Recruiting
        • Fukuiken Saiseikai Hospital /ID# 274835
      • Fukushima, Japan, 960-8530
        • Recruiting
        • Fukushima Red Cross Hospital /ID# 275322
      • Himeji, Japan, 670-8540
        • Recruiting
        • Japanease Red Cross Society Himeji Hospital /ID# 275590
      • Kochi, Japan, 780-0901
        • Recruiting
        • Kuniyoshi Hospital /ID# 271878
      • Saga, Japan, 840-8571
        • Recruiting
        • Saga-Ken Medical Centre Koseikan /ID# 274957
      • Saitama, Japan, 336-8522
        • Recruiting
        • Saitama City Hospital /ID# 266716
      • Sapporo, Japan, 060-0033
        • Recruiting
        • Sapporo Kosei General Hospital /ID# 267374
      • Tokyo, Japan, 173-8605
        • Recruiting
        • Teikyo University Hospital /ID# 274525
      • Tokyo, Japan, 173-8605
        • Recruiting
        • Teikyo University Hospital /ID# 274977
      • Tokyo, Japan, 169-0073
        • Recruiting
        • Tokyo Yamate Medical Center /ID# 275591
      • Toyonaka, Japan, 560-0055
        • Recruiting
        • Municipal Toyonaka Hospital /ID# 266712
      • Yamagata, Japan, 990-2292
        • Recruiting
        • Yamagata Prefectural Central Hospital - Yamagata /ID# 268819
      • Yamaguchi, Japan, 753-8519
        • Recruiting
        • Yamaguchi Red Cross Hospital /ID# 267381
    • Aichi-ken
      • Anjo-shi, Aichi-ken, Japan, 446-8602
        • Recruiting
        • Anjou Kousei Hospital /ID# 261872
      • Handa, Aichi-ken, Japan, 475-8599
        • Recruiting
        • Handa City Hospital /ID# 270446
      • Nagakute, Aichi-ken, Japan, 480-1195
        • Recruiting
        • Aichi Medical University Hospital /ID# 261871
      • Nagoya, Aichi-ken, Japan, 453-0016
        • Recruiting
        • Masuko Memorial Hospital /ID# 267420
      • Nagoya, Aichi-ken, Japan, 453-8511
        • Recruiting
        • Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219
      • Nagoya, Aichi-ken, Japan, 467-8602
        • Recruiting
        • Nagoya City University Hospital /ID# 275588
      • Toyohashi, Aichi-ken, Japan, 441-8570
        • Recruiting
        • Toyohashi Municipal Hospital /ID# 274975
      • Toyota-shi, Aichi-ken, Japan, 470-1219
        • Recruiting
        • Ieda Hospital /ID# 259754
    • Aomori
      • Hachinohe, Aomori, Japan, 031-0011
        • Recruiting
        • Hachinohe City Hospital /ID# 264183
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital - Kashiwanoha /ID# 262648
    • Ehime
      • Matsuyama, Ehime, Japan, 790-8524
        • Recruiting
        • Matsuyama Red Cross Hospital /ID# 266717
      • Uwajima, Ehime, Japan, 798-0061
        • Recruiting
        • Uwajima City Hospital /ID# 273444
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Recruiting
        • Fukuoka University Chikushi Hospital /ID# 262686
      • Fukuoka, Fukuoka, Japan, 813-0003
        • Recruiting
        • Sakemi clinic /ID# 275589
      • Kitakyushu, Fukuoka, Japan, 805-0050
        • Recruiting
        • Steel Memorial Yahata Hospital /ID# 272713
      • Kitakyushu, Fukuoka, Japan, 804-0093
        • Recruiting
        • Tobata Kyoritsu Hospital /ID# 273558
      • Kitakyushu-shi, Fukuoka, Japan, 802-0077
        • Recruiting
        • Kitakyushu Municipal Medical Center /ID# 276257
      • Kurume, Fukuoka, Japan, 839-0809
        • Recruiting
        • Hidaka Colon Proctology Clinic /ID# 268867
      • Kurume-shi, Fukuoka, Japan, 839-0863
        • Recruiting
        • Hakuai Clinic /ID# 261876
      • Onga-gun, Fukuoka, Japan, 807-0101
        • Recruiting
        • Ashiya Central Hospital /ID# 275324
    • Fukushima
      • Kōriyama, Fukushima, Japan, 963-8563
        • Recruiting
        • Southern Tohoku General Hospital /ID# 270447
    • Gifu
      • Gifu, Gifu, Japan, 501-1194
        • Recruiting
        • Gifu University Hospital /ID# 266711
      • Kakamigahara-shi, Gifu, Japan, 504-0907
        • Recruiting
        • Sakura Clinic /ID# 268344
    • Hiroshima
      • Fukuyama-shi, Hiroshima, Japan, 720-8520
        • Recruiting
        • National Hospital Organization Fukuyama Medical Center /ID# 261873
      • Hatsukaichi, Hiroshima, Japan, 738-8503
        • Recruiting
        • JA Hiroshima General Hospital /ID# 264432
      • Hiroshima, Hiroshima, Japan, 730-0017
        • Recruiting
        • Kaisei Clinic /ID# 261883
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 064-0919
        • Recruiting
        • Sapporo Ibd Clinic /ID# 281896
    • Hyōgo
      • Ako, Hyōgo, Japan, 678-0232
        • Recruiting
        • Ako-City Hospital /ID# 271276
      • Himeji, Hyōgo, Japan, 672-8501
        • Recruiting
        • Himeji Chuo Hospital /ID# 272714
      • Himeji-shi, Hyōgo, Japan, 670-0836
        • Recruiting
        • Hyogo Prefectural Harima-Himeji General Medical Center /ID# 274528
      • Itami, Hyōgo, Japan, 664-8540
        • Recruiting
        • Itami City Hospital /ID# 276258
      • Kobe, Hyōgo, Japan, 650-0015
        • Recruiting
        • Aoyama Clinic /ID# 262658
      • Kobe, Hyōgo, Japan, 650-0047
        • Recruiting
        • Kobe City Medical Center General Hospital /ID# 270950
      • Nishinomiya-shi, Hyōgo, Japan, 663-8501
        • Recruiting
        • Hyogo Medical University Hospital /ID# 267383
      • Ono, Hyōgo, Japan, 675-1327
        • Recruiting
        • Kita-Harima Medical Center /ID# 276256
    • Ibaraki
      • Tsukuba, Ibaraki, Japan, 305-0821
        • Recruiting
        • Tsukuba Endoscopy clinic /ID# 261880
    • Ishikawa-ken
      • Kanazawa, Ishikawa-ken, Japan, 920-8650
        • Recruiting
        • National Hospital Organization Kanazawa Medical Center /ID# 268820
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760-0017
        • Recruiting
        • Takamatsu Red Cross Hospital /ID# 268823
      • Takamatsu, Kagawa-ken, Japan, 761-8054
        • Recruiting
        • Maeda Hospital /ID# 275554
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 892-0843
        • Recruiting
        • Kagoshima IBD Gastroenterology Clinic /ID# 265505
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
        • Recruiting
        • Tokai University Hospital /ID# 270949
      • Kamakura-shi, Kanagawa, Japan, 247-0056
        • Recruiting
        • Gokeikai Ofuna Chuo Hospital /ID# 262649
      • Odawara-shi, Kanagawa, Japan, 250-0001
        • Recruiting
        • Shimizuogimachi Clinic /ID# 276278
      • Sagamihara-shi, Kanagawa, Japan, 252-0375
        • Recruiting
        • Kitasato University Hospital /ID# 276524
      • Yokohama, Kanagawa, Japan, 230-0012
        • Recruiting
        • Saiseikai Yokohama Tobu Hospital /ID# 264186
      • Yokohama, Kanagawa, Japan, 221-0855
        • Recruiting
        • Yokohama Municipal Citizen's Hospital /ID# 267375
      • Yokohama, Kanagawa, Japan, 223-0053
        • Recruiting
        • Inoue Gastroenterology Clinic /ID# 275555
      • Yokohama, Kanagawa, Japan, 220-0041
        • Recruiting
        • Matsushima Hospital /ID# 276486
    • Kochi
      • Kochi, Kochi, Japan, 780-8522
        • Recruiting
        • Chikamori Hospital /ID# 267382
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 862-0971
        • Recruiting
        • Coloproctology Center Takano Hospital /ID# 268868
    • Kyoto
      • Kyoto, Kyoto, Japan, 605-0981
        • Recruiting
        • Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660
      • Kyoto, Kyoto, Japan, 612-8555
        • Recruiting
        • National Hospital Organization Kyoto Medical Center /ID# 265461
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Recruiting
        • Mie University Hospital /ID# 262656
      • Yokkaichi-shi, Mie-ken, Japan, 510-0016
        • Recruiting
        • Yokkaichi Hazu Medical Center /ID# 260140
    • Nagano
      • Nagano, Nagano, Japan, 3818551
        • Recruiting
        • Nagano Municipal Hospital /ID# 262627
    • Nagasaki
      • Nagasaki, Nagasaki, Japan, 850-0058
        • Recruiting
        • Honda Internal Medicine and Endoscopy Clinic /ID# 275628
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870-0823
        • Recruiting
        • Ishida Clinic of IBD and Gastroenterology /ID# 261884
    • Okinawa
      • Ginowan-shi, Okinawa, Japan, 901-2725
        • Recruiting
        • University of the Ryukyus Hospital /ID# 264430
      • Naha, Okinawa, Japan, 902-0061
        • Recruiting
        • Naha City Hospital /ID# 261875
    • Osaka
      • Ibaraki-shi, Osaka, Japan, 567-0882
        • Recruiting
        • Seshimo Gastroy & Procto Clinic /ID# 271658
      • Moriguchi, Osaka, Japan, 570-0013
        • Recruiting
        • Moriguchi Keijinkai Hospital /ID# 268821
      • Osaka, Osaka, Japan, 530-0011
        • Recruiting
        • Kinshukai Infusion Clinic /ID# 261332
      • Osaka, Osaka, Japan, 540-0006
        • Recruiting
        • National Hospital Organization Osaka National Hospital /ID# 264230
      • Osaka, Osaka, Japan, 545-8586
        • Recruiting
        • Osaka Metropolitan University Hospital /ID# 273559
      • Osaka, Osaka, Japan, 550-0025
        • Recruiting
        • Tane General Hospital /ID# 268871
      • Sakai, Osaka, Japan, 591-8025
        • Recruiting
        • Osaka Rosai Hospital /ID# 267379
      • Takatsuki, Osaka, Japan, 569-0086
        • Recruiting
        • Fujita Gastroenterology Hospital /ID# 275410
    • Saitama
      • Ageo, Saitama, Japan, 362-0075
        • Recruiting
        • Ohmori Toshihide Gastrointestinal Clinic /ID# 276192
      • Kawagoe, Saitama, Japan, 350-8550
        • Recruiting
        • Saitama Medical Center /ID# 270948
      • Saitama-shi, Saitama, Japan, 336-0963
        • Recruiting
        • Tokitokai Tokito clinic /ID# 262661
      • Tokorozawa, Saitama, Japan, 359-1141
        • Recruiting
        • Tokorozawa Proctogic Hospital /ID# 268870
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8061
        • Recruiting
        • Kato Clinic /ID# 262650
      • Shizuoka, Shizuoka, Japan, 420-0881
        • Recruiting
        • Shizuoka Aoi Clinic /ID# 267376
      • Sizuoka-shi, Shizuoka, Japan, 420-0859
        • Recruiting
        • Saigusa Clinic Of Coloproctolo /ID# 275627
      • Sunto-gun, Shizuoka, Japan, 411-8611
        • Recruiting
        • NHO Shizuoka Medical Center /ID# 275551
    • Tochigi
      • Mibu, Tochigi, Japan, 321-0293
        • Recruiting
        • Dokkyo Medical University Hospital /ID# 266710
      • Utsunomiya, Tochigi, Japan, 321-0974
        • Recruiting
        • Saiseikai Utsunomiya Hospital /ID# 261878
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Recruiting
        • Juntendo University Hospital /ID# 265452
      • Chuo-ku, Tokyo, Japan, 104-0061
        • Recruiting
        • Ginza Central Clinic /ID# 261881
      • Koganei-shi, Tokyo, Japan, 184-0004
        • Recruiting
        • Koganei Tsurukame Clinic /ID# 271660
      • Minato-ku, Tokyo, Japan, 108-8642
        • Recruiting
        • Kitasato University Kitasato Institute Hospital /ID# 268345
      • Setagaya-ku, Tokyo, Japan, 155-0032
        • Recruiting
        • Ohori IBD Clinic /ID# 261882
      • Shibuya-ku, Tokyo, Japan, 151-0053
        • Recruiting
        • Shinjuku Tsurukame Clinic /ID# 276485
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital /ID# 262683
      • Shinjuku-ku, Tokyo, Japan, 162-8666
        • Recruiting
        • Tokyo Women's Medical University Hospital /ID# 274527
      • Sumida-ku, Tokyo, Japan, 130-8587
        • Recruiting
        • Fraternity Memorial Hospital /ID# 274976
    • Toyama
      • Toyama, Toyama, Japan, 939-8085
        • Recruiting
        • Yokota Memorial Hospital /ID# 266714
    • Wakayama
      • Wakayama, Wakayama, Japan, 640-8558
        • Recruiting
        • Japanese Red Cross Wakayama Medical Center /ID# 268822
      • Wakayama, Wakayama, Japan, 641-8510
        • Recruiting
        • Wakayama Medical University Hospital /ID# 262685
    • Yamaguchi
      • Ube, Yamaguchi, Japan, 755-0155
        • Recruiting
        • Sentohill Hospital /ID# 268869
    • Yamanashi
      • Kofu, Yamanashi, Japan, 400-0027
        • Recruiting
        • Yamanashi Prefectural Central Hospital /ID# 274526

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Children and Adult participants with Crohn's disease (CD) in Japan.

Description

Inclusion Criteria:

  • Diagnosed with moderately to severely active Crohn's disease (CD).
  • Has been prescribed upadacitinib for CD as per most current local approved label after its approval for CD in Japan.
  • Within 14 days from the commencement of upadacitinib induction treatment for CD at the participating institution.

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 with upadacitinib for CD at the participation to this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Upadacitinib
Participants will receive upadacitinib as prescribed by their physician according to local label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Drug Related Serious Infections
Time Frame: Up to 64 Weeks
Pecentage of participants with serious infections.
Up to 64 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2023

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

May 1, 2027

Study Registration Dates

First Submitted

August 29, 2023

First Submitted That Met QC Criteria

August 29, 2023

First Posted (Actual)

September 5, 2023

Study Record Updates

Last Update Posted (Actual)

February 24, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P24-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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