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

NCT06023030 | Recruiting

• 1 other identifier: P24-080
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 104

Brief 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.

Conditions

Crohn's Disease

Keywords

Crohn's disease; Upadacitinib

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with Drug Related Serious Infections

  Pecentage of participants with serious infections.

  Up to 64 Weeks

Study Arms (1)

Upadacitinib

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (104)

Anjou Kousei Hospital /ID# 261872

Anjo-shi, Aichi-ken, 446-8602, Japan

RECRUITING

Handa City Hospital /ID# 270446

Handa, Aichi-ken, 475-8599, Japan

RECRUITING

Aichi Medical University Hospital /ID# 261871

Nagakute, Aichi-ken, 480-1195, Japan

RECRUITING

Masuko Memorial Hospital /ID# 267420

Nagoya, Aichi-ken, 453-0016, Japan

RECRUITING

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

Nagoya, Aichi-ken, 453-8511, Japan

RECRUITING

Nagoya City University Hospital /ID# 275588

Nagoya, Aichi-ken, 467-8602, Japan

RECRUITING

Toyohashi Municipal Hospital /ID# 274975

Toyohashi, Aichi-ken, 441-8570, Japan

RECRUITING

Ieda Hospital /ID# 259754

Toyota-shi, Aichi-ken, 470-1219, Japan

RECRUITING

Hachinohe City Hospital /ID# 264183

Hachinohe, Aomori, 031-0011, Japan

RECRUITING

Tsujinaka Hospital - Kashiwanoha /ID# 262648

Kashiwa-shi, Chiba, 277-0871, Japan

RECRUITING

Matsuyama Red Cross Hospital /ID# 266717

Matsuyama, Ehime, 790-8524, Japan

RECRUITING

Uwajima City Hospital /ID# 273444

Uwajima, Ehime, 798-0061, Japan

RECRUITING

Fukuoka University Chikushi Hospital /ID# 262686

Chikushino-shi, Fukuoka, 818-8502, Japan

RECRUITING

Sakemi clinic /ID# 275589

Fukuoka, Fukuoka, 813-0003, Japan

RECRUITING

Tobata Kyoritsu Hospital /ID# 273558

Kitakyushu, Fukuoka, 804-0093, Japan

RECRUITING

Steel Memorial Yahata Hospital /ID# 272713

Kitakyushu, Fukuoka, 805-0050, Japan

RECRUITING

Kitakyushu Municipal Medical Center /ID# 276257

Kitakyushu-shi, Fukuoka, 802-0077, Japan

RECRUITING

Hidaka Colon Proctology Clinic /ID# 268867

Kurume, Fukuoka, 839-0809, Japan

RECRUITING

Hakuai Clinic /ID# 261876

Kurume-shi, Fukuoka, 839-0863, Japan

RECRUITING

Ashiya Central Hospital /ID# 275324

Onga-gun, Fukuoka, 807-0101, Japan

RECRUITING

Southern Tohoku General Hospital /ID# 270447

Kōriyama, Fukushima, 963-8563, Japan

RECRUITING

Gifu University Hospital /ID# 266711

Gifu, Gifu, 501-1194, Japan

RECRUITING

Sakura Clinic /ID# 268344

Kakamigahara-shi, Gifu, 504-0907, Japan

RECRUITING

National Hospital Organization Fukuyama Medical Center /ID# 261873

Fukuyama-shi, Hiroshima, 720-8520, Japan

RECRUITING

JA Hiroshima General Hospital /ID# 264432

Hatsukaichi, Hiroshima, 738-8503, Japan

RECRUITING

Kaisei Clinic /ID# 261883

Hiroshima, Hiroshima, 730-0017, Japan

RECRUITING

Sapporo Ibd Clinic /ID# 281896

Sapporo, Hokkaido, 064-0919, Japan

RECRUITING

Ako-City Hospital /ID# 271276

Ako, Hyōgo, 678-0232, Japan

RECRUITING

Himeji Chuo Hospital /ID# 272714

Himeji, Hyōgo, 672-8501, Japan

RECRUITING

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

Himeji-shi, Hyōgo, 670-0836, Japan

RECRUITING

Itami City Hospital /ID# 276258

Itami, Hyōgo, 664-8540, Japan

RECRUITING

Aoyama Clinic /ID# 262658

Kobe, Hyōgo, 650-0015, Japan

RECRUITING

Kobe City Medical Center General Hospital /ID# 270950

Kobe, Hyōgo, 650-0047, Japan

RECRUITING

Hyogo Medical University Hospital /ID# 267383

Nishinomiya-shi, Hyōgo, 663-8501, Japan

RECRUITING

Kita-Harima Medical Center /ID# 276256

Ono, Hyōgo, 675-1327, Japan

RECRUITING

Tsukuba Endoscopy clinic /ID# 261880

Tsukuba, Ibaraki, 305-0821, Japan

RECRUITING

National Hospital Organization Kanazawa Medical Center /ID# 268820

Kanazawa, Ishikawa-ken, 920-8650, Japan

RECRUITING

Takamatsu Red Cross Hospital /ID# 268823

Takamatsu, Kagawa-ken, 760-0017, Japan

RECRUITING

Maeda Hospital /ID# 275554

Takamatsu, Kagawa-ken, 761-8054, Japan

RECRUITING

Kagoshima IBD Gastroenterology Clinic /ID# 265505

Kagoshima, Kagoshima-ken, 892-0843, Japan

RECRUITING

Tokai University Hospital /ID# 270949

Isehara, Kanagawa, 259-1193, Japan

RECRUITING

Gokeikai Ofuna Chuo Hospital /ID# 262649

Kamakura-shi, Kanagawa, 247-0056, Japan

RECRUITING

Shimizuogimachi Clinic /ID# 276278

Odawara-shi, Kanagawa, 250-0001, Japan

RECRUITING

Kitasato University Hospital /ID# 276524

Sagamihara-shi, Kanagawa, 252-0375, Japan

RECRUITING

Matsushima Hospital /ID# 276486

Yokohama, Kanagawa, 220-0041, Japan

RECRUITING

Yokohama Municipal Citizen's Hospital /ID# 267375

Yokohama, Kanagawa, 221-0855, Japan

RECRUITING

Inoue Gastroenterology Clinic /ID# 275555

Yokohama, Kanagawa, 223-0053, Japan

RECRUITING

Saiseikai Yokohama Tobu Hospital /ID# 264186

Yokohama, Kanagawa, 230-0012, Japan

RECRUITING

Chikamori Hospital /ID# 267382

Kochi, Kochi, 780-8522, Japan

RECRUITING

Coloproctology Center Takano Hospital /ID# 268868

Kumamoto, Kumamoto, 862-0971, Japan

RECRUITING

Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660

Kyoto, Kyoto, 605-0981, Japan

RECRUITING

National Hospital Organization Kyoto Medical Center /ID# 265461

Kyoto, Kyoto, 612-8555, Japan

RECRUITING

Mie University Hospital /ID# 262656

Tsu, Mie-ken, 514-8507, Japan

RECRUITING

Yokkaichi Hazu Medical Center /ID# 260140

Yokkaichi-shi, Mie-ken, 510-0016, Japan

RECRUITING

Nagano Municipal Hospital /ID# 262627

Nagano, Nagano, 3818551, Japan

RECRUITING

Honda Internal Medicine and Endoscopy Clinic /ID# 275628

Nagasaki, Nagasaki, 850-0058, Japan

RECRUITING

Ishida Clinic of IBD and Gastroenterology /ID# 261884

Ōita, Oita Prefecture, 870-0823, Japan

RECRUITING

University of the Ryukyus Hospital /ID# 264430

Ginowan-shi, Okinawa, 901-2725, Japan

RECRUITING

Naha City Hospital /ID# 261875

Naha, Okinawa, 902-0061, Japan

RECRUITING

Seshimo Gastroy & Procto Clinic /ID# 271658

Ibaraki-shi, Osaka, 567-0882, Japan

RECRUITING

Moriguchi Keijinkai Hospital /ID# 268821

Moriguchi, Osaka, 570-0013, Japan

RECRUITING

Kinshukai Infusion Clinic /ID# 261332

Osaka, Osaka, 530-0011, Japan

RECRUITING

National Hospital Organization Osaka National Hospital /ID# 264230

Osaka, Osaka, 540-0006, Japan

RECRUITING

Osaka Metropolitan University Hospital /ID# 273559

Osaka, Osaka, 545-8586, Japan

RECRUITING

Tane General Hospital /ID# 268871

Osaka, Osaka, 550-0025, Japan

RECRUITING

Osaka Rosai Hospital /ID# 267379

Sakai, Osaka, 591-8025, Japan

RECRUITING

Fujita Gastroenterology Hospital /ID# 275410

Takatsuki, Osaka, 569-0086, Japan

RECRUITING

Ohmori Toshihide Gastrointestinal Clinic /ID# 276192

Ageo, Saitama, 362-0075, Japan

RECRUITING

Saitama Medical Center /ID# 270948

Kawagoe, Saitama, 350-8550, Japan

RECRUITING

Tokitokai Tokito clinic /ID# 262661

Saitama-shi, Saitama, 336-0963, Japan

RECRUITING

Tokorozawa Proctogic Hospital /ID# 268870

Tokorozawa, Saitama, 359-1141, Japan

RECRUITING

Kato Clinic /ID# 262650

Hamamatsu, Shizuoka, 432-8061, Japan

RECRUITING

Shizuoka Aoi Clinic /ID# 267376

Shizuoka, Shizuoka, 420-0881, Japan

RECRUITING

Saigusa Clinic Of Coloproctolo /ID# 275627

Sizuoka-shi, Shizuoka, 420-0859, Japan

RECRUITING

NHO Shizuoka Medical Center /ID# 275551

Sunto-gun, Shizuoka, 411-8611, Japan

RECRUITING

Dokkyo Medical University Hospital /ID# 266710

Mibu, Tochigi, 321-0293, Japan

RECRUITING

Saiseikai Utsunomiya Hospital /ID# 261878

Utsunomiya, Tochigi, 321-0974, Japan

RECRUITING

Juntendo University Hospital /ID# 265452

Bunkyo-ku, Tokyo, 113-8431, Japan

RECRUITING

Ginza Central Clinic /ID# 261881

Chuo-ku, Tokyo, 104-0061, Japan

RECRUITING

Koganei Tsurukame Clinic /ID# 271660

Koganei-shi, Tokyo, 184-0004, Japan

RECRUITING

Kitasato University Kitasato Institute Hospital /ID# 268345

Minato-ku, Tokyo, 108-8642, Japan

RECRUITING

Ohori IBD Clinic /ID# 261882

Setagaya-ku, Tokyo, 155-0032, Japan

RECRUITING

Shinjuku Tsurukame Clinic /ID# 276485

Shibuya-ku, Tokyo, 151-0053, Japan

RECRUITING

Tokyo Medical University Hospital /ID# 262683

Shinjuku-ku, Tokyo, 160-0023, Japan

RECRUITING

Tokyo Women's Medical University Hospital /ID# 274527

Shinjuku-ku, Tokyo, 162-8666, Japan

RECRUITING

Fraternity Memorial Hospital /ID# 274976

Sumida-ku, Tokyo, 130-8587, Japan

RECRUITING

Yokota Memorial Hospital /ID# 266714

Toyama, Toyama, 939-8085, Japan

RECRUITING

Japanese Red Cross Wakayama Medical Center /ID# 268822

Wakayama, Wakayama, 640-8558, Japan

RECRUITING

Wakayama Medical University Hospital /ID# 262685

Wakayama, Wakayama, 641-8510, Japan

RECRUITING

Sentohill Hospital /ID# 268869

Ube, Yamaguchi, 755-0155, Japan

RECRUITING

Yamanashi Prefectural Central Hospital /ID# 274526

Kofu, Yamanashi, 400-0027, Japan

RECRUITING

Fukuiken Saiseikai Hospital /ID# 274835

Fukui, 918-8235, Japan

RECRUITING

Fukushima Red Cross Hospital /ID# 275322

Fukushima, 960-8530, Japan

RECRUITING

Japanease Red Cross Society Himeji Hospital /ID# 275590

Himeji, 670-8540, Japan

RECRUITING

Kuniyoshi Hospital /ID# 271878

Kochi, 780-0901, Japan

RECRUITING

Saga-Ken Medical Centre Koseikan /ID# 274957

Saga, 840-8571, Japan

RECRUITING

Saitama City Hospital /ID# 266716

Saitama, 336-8522, Japan

RECRUITING

Sapporo Kosei General Hospital /ID# 267374

Sapporo, 060-0033, Japan

RECRUITING

Tokyo Yamate Medical Center /ID# 275591

Tokyo, 169-0073, Japan

RECRUITING

Teikyo University Hospital /ID# 274525

Tokyo, 173-8605, Japan

RECRUITING

Teikyo University Hospital /ID# 274977

Tokyo, 173-8605, Japan

RECRUITING

Municipal Toyonaka Hospital /ID# 266712

Toyonaka, 560-0055, Japan

RECRUITING

Yamagata Prefectural Central Hospital - Yamagata /ID# 268819

Yamagata, 990-2292, Japan

RECRUITING

Yamaguchi Red Cross Hospital /ID# 267381

Yamaguchi, 753-8519, Japan

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

AbbVie GK Clinical Trial Registration Desk

CONTACT

+81-3-4577-1111; abbvie_jpn_info_clingov@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 5, 2023
• Study Start: July 28, 2023
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: February 24, 2026

Record last verified: 2026-02

Locations

JP (104)