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

NCT ID: NCT06023030

Last Updated: 2025-04-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-28

Study Completion Date

2026-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Crohn's Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Upadacitinib

Participants will receive upadacitinib as prescribed by their physician according to local label.

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Locations

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Anjou Kousei Hospital /ID# 261872

Anjo-shi, Aichi-ken, Japan

Site Status RECRUITING

Handa City Hospital /ID# 270446

Handa, Aichi-ken, Japan

Site Status RECRUITING

Aichi Medical University Hospital /ID# 261871

Nagakute, Aichi-ken, Japan

Site Status RECRUITING

Masuko Memorial Hospital /ID# 267420

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Nagoya City University Hospital /ID# 275588

Nagoya, Aichi-ken, Japan

Site Status RECRUITING

Toyohashi Municipal Hospital /ID# 274975

Toyohashi, Aichi-ken, Japan

Site Status RECRUITING

Ieda Hospital /ID# 259754

Toyota-shi, Aichi-ken, Japan

Site Status RECRUITING

Hachinohe City Hospital /ID# 264183

Hachinohe, Aomori, Japan

Site Status RECRUITING

Tsujinaka Hospital Kashiwanoha /ID# 262648

Kashiwa-shi, Chiba, Japan

Site Status RECRUITING

Matsuyama Red Cross Hospital /ID# 266717

Matsuyama, Ehime, Japan

Site Status RECRUITING

Uwajima City Hospital /ID# 273444

Uwajima, Ehime, Japan

Site Status RECRUITING

Fukuoka University Chikushi Hospital /ID# 262686

Chikushino-shi, Fukuoka, Japan

Site Status RECRUITING

Kitakyushu Municipal Medical Center /ID# 276257

Kitakyushu, Fukuoka, Japan

Site Status RECRUITING

Tobata Kyoritsu Hospital /ID# 273558

Kitakyushu, Fukuoka, Japan

Site Status RECRUITING

Steel Memorial Yahata Hospital /ID# 272713

Kitakyushu, Fukuoka, Japan

Site Status RECRUITING

Hidaka Colon Proctology Clinic /ID# 268867

Kurume, Fukuoka, Japan

Site Status RECRUITING

Hakuai Clinic /ID# 261876

Kurume-shi, Fukuoka, Japan

Site Status RECRUITING

Ashiya Central Hospital /ID# 275324

Onga-gun, Fukuoka, Japan

Site Status RECRUITING

Southern Tohoku General Hospital /ID# 270447

Kōriyama, Fukushima, Japan

Site Status RECRUITING

Sakura Clinic /ID# 268344

Kakamigahara-shi, Gifu, Japan

Site Status RECRUITING

NHO Fukuyama Medical Center /ID# 261873

Fukuyama-shi, Hiroshima, Japan

Site Status RECRUITING

JA Hiroshima General Hospital /ID# 264432

Hatsukaichi, Hiroshima, Japan

Site Status RECRUITING

Kaisei Clinic /ID# 261883

Hiroshima, Hiroshima, Japan

Site Status RECRUITING

Ako-City Hospital /ID# 271276

Ako, Hyōgo, Japan

Site Status RECRUITING

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

Himeji, Hyōgo, Japan

Site Status RECRUITING

Himeji Chuo Hospital /ID# 272714

Himeji, Hyōgo, Japan

Site Status RECRUITING

Itami City Hospital /ID# 276258

Itami, Hyōgo, Japan

Site Status RECRUITING

Aoyama Clinic /ID# 262658

Kobe, Hyōgo, Japan

Site Status RECRUITING

Kobe City Medical Center General Hospital /ID# 270950

Kobe, Hyōgo, Japan

Site Status RECRUITING

Hyogo Medical University Hospital /ID# 267383

Nishinomiya, Hyōgo, Japan

Site Status RECRUITING

Kita-Harima Medical Center /ID# 276256

Ono, Hyōgo, Japan

Site Status RECRUITING

Tsukuba Endoscopy clinic /ID# 261880

Tsukuba, Ibaraki, Japan

Site Status RECRUITING

National Hospital Organization Kanazawa Medical Center /ID# 268820

Kanazawa, Ishikawa-ken, Japan

Site Status RECRUITING

Takamatsu Red Cross Hospital /ID# 268823

Takamatsu, Kagawa-ken, Japan

Site Status RECRUITING

Maeda Hospital /ID# 275554

Takamatsu, Kagawa-ken, Japan

Site Status RECRUITING

Tokai University Hospital /ID# 270949

Isehara, Kanagawa, Japan

Site Status RECRUITING

Gokeikai Ofuna Chuo Hospital /ID# 262649

Kamakura-shi, Kanagawa, Japan

Site Status RECRUITING

Shimizuogimachi Clinic /ID# 276278

Odawara-shi, Kanagawa, Japan

Site Status RECRUITING

Kitasato University Hospital /ID# 276524

Sagamihara-shi, Kanagawa, Japan

Site Status RECRUITING

Yokohama Municipal Citizen's Hospital /ID# 267375

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Inoue Gastroenterology Clinic /ID# 275555

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Saiseikai Yokohama Tobu Hospital /ID# 264186

Yokohama, Kanagawa, Japan

Site Status RECRUITING

Chikamori Hospital /ID# 267382

Kochi, Kochi, Japan

Site Status RECRUITING

Coloproctology Center Takano Hospital /ID# 268868

Kumamoto, Kumamoto, Japan

Site Status RECRUITING

Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660

Kyoto, Kyoto, Japan

Site Status RECRUITING

National Hospital Organization Kyoto Medical Center /ID# 265461

Kyoto, Kyoto, Japan

Site Status RECRUITING

Mie University Hospital /ID# 262656

Tsu, Mie-ken, Japan

Site Status RECRUITING

Yokkaichi Hazu Medical Center /ID# 260140

Yokkaichi-shi, Mie-ken, Japan

Site Status RECRUITING

Nagano Municipal Hospital /ID# 262627

Nagano, Nagano, Japan

Site Status RECRUITING

Honda Internal Medicine and Endoscopy Clinic /ID# 275628

Nagasaki, Nagasaki, Japan

Site Status RECRUITING

Ishida Clinic of IBD and Gastroenterology /ID# 261884

Ōita, Oita Prefecture, Japan

Site Status RECRUITING

University of the Ryukyus Hospital /ID# 264430

Ginowan-shi, Okinawa, Japan

Site Status RECRUITING

Naha City Hospital /ID# 261875

Naha, Okinawa, Japan

Site Status RECRUITING

Seshimo Gastroy & Procto Clinic /ID# 271658

Ibaraki-shi, Osaka, Japan

Site Status RECRUITING

Moriguchi Keijinkai Hospital /ID# 268821

Moriguchi, Osaka, Japan

Site Status RECRUITING

Kinshukai Infusion Clinic /ID# 261332

Osaka, Osaka, Japan

Site Status RECRUITING

National Hospital Organization Osaka National Hospital /ID# 264230

Osaka, Osaka, Japan

Site Status RECRUITING

Osaka Metropolitan University Hospital /ID# 273559

Osaka, Osaka, Japan

Site Status RECRUITING

Tane General Hospital /ID# 268871

Osaka, Osaka, Japan

Site Status RECRUITING

Osaka Rosai Hospital /ID# 267379

Sakai, Osaka, Japan

Site Status RECRUITING

Fujita Gastroenterology Hospital /ID# 275410

Takatsuki, Osaka, Japan

Site Status RECRUITING

Ohmori Toshihide Gastrointestinal Clinic /ID# 276192

Ageo, Saitama, Japan

Site Status RECRUITING

Saitama Medical Center /ID# 270948

Kawagoe, Saitama, Japan

Site Status RECRUITING

Tokitokai Tokito clinic /ID# 262661

Saitama-shi, Saitama, Japan

Site Status RECRUITING

Tokorozawa Proctogic Hospital /ID# 268870

Tokorozawa, Saitama, Japan

Site Status RECRUITING

Kato Clinic /ID# 262650

Hamamatsu, Shizuoka, Japan

Site Status RECRUITING

Shizuoka Medical Center /ID# 275551

Shimizu, Shizuoka, Japan

Site Status RECRUITING

Shizuoka Aoi Clinic /ID# 267376

Shizuoka, Shizuoka, Japan

Site Status RECRUITING

Saigusa Clinic Of Coloproctolo /ID# 275627

Sizuoka-shi, Shizuoka, Japan

Site Status RECRUITING

Dokkyo Medical University Hospital /ID# 266710

Mibu, Tochigi, Japan

Site Status RECRUITING

Saiseikai Utsunomiya Hospital /ID# 261878

Utsunomiya, Tochigi, Japan

Site Status RECRUITING

Juntendo University Hospital /ID# 265452

Bunkyo-ku, Tokyo, Japan

Site Status RECRUITING

Ginza Central Clinic /ID# 261881

Chuo-ku, Tokyo, Japan

Site Status RECRUITING

Koganei Tsurukame Clinic /ID# 271660

Koganei-shi, Tokyo, Japan

Site Status RECRUITING

Ohori IBD Clinic /ID# 261882

Setagaya-ku, Tokyo, Japan

Site Status RECRUITING

Shinjuku Tsurukame Clinic /ID# 276485

Shibuya City, Tokyo, Japan

Site Status RECRUITING

Tokyo Medical University Hospital /ID# 262683

Shinjuku-ku, Tokyo, Japan

Site Status RECRUITING

Tokyo Women'S Medical University Hospital /ID# 274527

Shinjuku-ku, Tokyo, Japan

Site Status RECRUITING

The Fraternity Memorial Hospital /ID# 274976

Sumida-ku, Tokyo, Japan

Site Status RECRUITING

Yokota Memorial Hospital /ID# 266714

Toyama, Toyama, Japan

Site Status RECRUITING

Wakayama Medical University Hospital /ID# 262685

Wakayama, Wakayama, Japan

Site Status RECRUITING

Sentohill Hospital /ID# 268869

Ube, Yamaguchi, Japan

Site Status RECRUITING

Yamanashi Prefectural Central Hospital /ID# 274526

Kofu, Yamanashi, Japan

Site Status RECRUITING

Fukuiken Saiseikai Hospital /ID# 274835

Fukui, , Japan

Site Status RECRUITING

Fukushima Red Cross Hospital /ID# 275322

Fukushima, , Japan

Site Status RECRUITING

Gifu University Hospital /ID# 266711

Gifu, , Japan

Site Status RECRUITING

Japanease Red Cross Society Himeji Hospital /ID# 275590

Himeji, , Japan

Site Status RECRUITING

Kagoshima IBD Gastroenterology Clinic /ID# 265505

Kagoshima, , Japan

Site Status RECRUITING

Kuniyoshi Hospital /ID# 271878

Kochi, , Japan

Site Status RECRUITING

Saga-Ken Medical Centre Koseikan /ID# 274957

Saga, , Japan

Site Status RECRUITING

Saitama City Hospital /ID# 266716

Saitama, , Japan

Site Status RECRUITING

Sapporo Kosei General Hospital /ID# 267374

Sapporo, , Japan

Site Status RECRUITING

Kitasato University Kitasato Institute Hospital /ID# 268345

Tokyo, , Japan

Site Status RECRUITING

Tokyo Yamate Medical Center /ID# 275591

Tokyo, , Japan

Site Status RECRUITING

Teikyo University Hospital /ID# 274525

Tokyo, , Japan

Site Status RECRUITING

Teikyo University Hospital /ID# 274977

Tokyo, , Japan

Site Status RECRUITING

Municipal Toyonaka Hospital /ID# 266712

Toyonaka, , Japan

Site Status RECRUITING

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

Wakayama, , Japan

Site Status RECRUITING

Yamagata Prefectural Central Hospital - Yamagata /ID# 268819

Yamagata, , Japan

Site Status RECRUITING

Yamaguchi Red Cross Hospital /ID# 267381

Yamaguchi, , Japan

Site Status RECRUITING

Countries

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Japan

Central Contacts

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AbbVie GK Clinical Trial Registration Desk

Role: CONTACT

+81-3-4577-1111

Related Links

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Other Identifiers

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P24-080

Identifier Type: -

Identifier Source: org_study_id

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