RecruitingNCT06023030

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

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

Sponsor

AbbVie

Enrollment

240 participants

Start Date

Jul 28, 2023

Study Type

OBSERVATIONAL

Conditions

Crohn's Disease

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

Min Age: 15 Years

Plain Language Summary

Simplified for easier understanding

This observational study (no experimental treatment — researchers just observe) is tracking how well a medication called upadacitinib works for people in Japan who have moderate to severe Crohn's disease. Crohn's disease causes painful inflammation in the digestive tract. The goal is to collect real-world data on how patients respond over time. **You may be eligible if...** - You have been diagnosed with moderate to severe Crohn's disease - Your doctor has already prescribed upadacitinib for your Crohn's disease in Japan - You have started upadacitinib within the last 14 days **You may NOT be eligible if...** - You are currently enrolled in another clinical trial - Upadacitinib is not suitable for you based on medical guidelines - You have previously used upadacitinib for Crohn's disease before and are continuing that same treatment Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(104)

Anjou Kousei Hospital /ID# 261872

Anjo-shi, Aichi-ken, Japan

Handa City Hospital /ID# 270446

Handa, Aichi-ken, Japan

Aichi Medical University Hospital /ID# 261871

Nagakute, Aichi-ken, Japan

Masuko Memorial Hospital /ID# 267420

Nagoya, Aichi-ken, Japan

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

Nagoya, Aichi-ken, Japan

Nagoya City University Hospital /ID# 275588

Nagoya, Aichi-ken, Japan

Toyohashi Municipal Hospital /ID# 274975

Toyohashi, Aichi-ken, Japan

Ieda Hospital /ID# 259754

Toyota-shi, Aichi-ken, Japan

Hachinohe City Hospital /ID# 264183

Hachinohe, Aomori, Japan

Tsujinaka Hospital - Kashiwanoha /ID# 262648

Kashiwa-shi, Chiba, Japan

Matsuyama Red Cross Hospital /ID# 266717

Matsuyama, Ehime, Japan

Uwajima City Hospital /ID# 273444

Uwajima, Ehime, Japan

Fukuoka University Chikushi Hospital /ID# 262686

Chikushino-shi, Fukuoka, Japan

Sakemi clinic /ID# 275589

Fukuoka, Fukuoka, Japan

Tobata Kyoritsu Hospital /ID# 273558

Kitakyushu, Fukuoka, Japan

Steel Memorial Yahata Hospital /ID# 272713

Kitakyushu, Fukuoka, Japan

Kitakyushu Municipal Medical Center /ID# 276257

Kitakyushu-shi, Fukuoka, Japan

Hidaka Colon Proctology Clinic /ID# 268867

Kurume, Fukuoka, Japan

Hakuai Clinic /ID# 261876

Kurume-shi, Fukuoka, Japan

Ashiya Central Hospital /ID# 275324

Onga-gun, Fukuoka, Japan

Southern Tohoku General Hospital /ID# 270447

Kōriyama, Fukushima, Japan

Gifu University Hospital /ID# 266711

Gifu, Gifu, Japan

Sakura Clinic /ID# 268344

Kakamigahara-shi, Gifu, Japan

National Hospital Organization Fukuyama Medical Center /ID# 261873

Fukuyama-shi, Hiroshima, Japan

JA Hiroshima General Hospital /ID# 264432

Hatsukaichi, Hiroshima, Japan

Kaisei Clinic /ID# 261883

Hiroshima, Hiroshima, Japan

Sapporo Ibd Clinic /ID# 281896

Sapporo, Hokkaido, Japan

Ako-City Hospital /ID# 271276

Ako, Hyōgo, Japan

Himeji Chuo Hospital /ID# 272714

Himeji, Hyōgo, Japan

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

Himeji-shi, Hyōgo, Japan

Itami City Hospital /ID# 276258

Itami, Hyōgo, Japan

Aoyama Clinic /ID# 262658

Kobe, Hyōgo, Japan

Kobe City Medical Center General Hospital /ID# 270950

Kobe, Hyōgo, Japan

Hyogo Medical University Hospital /ID# 267383

Nishinomiya-shi, Hyōgo, Japan

Kita-Harima Medical Center /ID# 276256

Ono, Hyōgo, Japan

Tsukuba Endoscopy clinic /ID# 261880

Tsukuba, Ibaraki, Japan

National Hospital Organization Kanazawa Medical Center /ID# 268820

Kanazawa, Ishikawa-ken, Japan

Takamatsu Red Cross Hospital /ID# 268823

Takamatsu, Kagawa-ken, Japan

Maeda Hospital /ID# 275554

Takamatsu, Kagawa-ken, Japan

Kagoshima IBD Gastroenterology Clinic /ID# 265505

Kagoshima, Kagoshima-ken, Japan

Tokai University Hospital /ID# 270949

Isehara, Kanagawa, Japan

Gokeikai Ofuna Chuo Hospital /ID# 262649

Kamakura-shi, Kanagawa, Japan

Shimizuogimachi Clinic /ID# 276278

Odawara-shi, Kanagawa, Japan

Kitasato University Hospital /ID# 276524

Sagamihara-shi, Kanagawa, Japan

Matsushima Hospital /ID# 276486

Yokohama, Kanagawa, Japan

Yokohama Municipal Citizen's Hospital /ID# 267375

Yokohama, Kanagawa, Japan

Inoue Gastroenterology Clinic /ID# 275555

Yokohama, Kanagawa, Japan

Saiseikai Yokohama Tobu Hospital /ID# 264186

Yokohama, Kanagawa, Japan

Chikamori Hospital /ID# 267382

Kochi, Kochi, Japan

Coloproctology Center Takano Hospital /ID# 268868

Kumamoto, Kumamoto, Japan

Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660

Kyoto, Kyoto, Japan

National Hospital Organization Kyoto Medical Center /ID# 265461

Kyoto, Kyoto, Japan

Mie University Hospital /ID# 262656

Tsu, Mie-ken, Japan

Yokkaichi Hazu Medical Center /ID# 260140

Yokkaichi-shi, Mie-ken, Japan

Nagano Municipal Hospital /ID# 262627

Nagano, Nagano, Japan

Honda Internal Medicine and Endoscopy Clinic /ID# 275628

Nagasaki, Nagasaki, Japan

Ishida Clinic of IBD and Gastroenterology /ID# 261884

Ōita, Oita Prefecture, Japan

University of the Ryukyus Hospital /ID# 264430

Ginowan-shi, Okinawa, Japan

Naha City Hospital /ID# 261875

Naha, Okinawa, Japan

Seshimo Gastroy & Procto Clinic /ID# 271658

Ibaraki-shi, Osaka, Japan

Moriguchi Keijinkai Hospital /ID# 268821

Moriguchi, Osaka, Japan

Kinshukai Infusion Clinic /ID# 261332

Osaka, Osaka, Japan

National Hospital Organization Osaka National Hospital /ID# 264230

Osaka, Osaka, Japan

Osaka Metropolitan University Hospital /ID# 273559

Osaka, Osaka, Japan

Tane General Hospital /ID# 268871

Osaka, Osaka, Japan

Osaka Rosai Hospital /ID# 267379

Sakai, Osaka, Japan

Fujita Gastroenterology Hospital /ID# 275410

Takatsuki, Osaka, Japan

Ohmori Toshihide Gastrointestinal Clinic /ID# 276192

Ageo, Saitama, Japan

Saitama Medical Center /ID# 270948

Kawagoe, Saitama, Japan

Tokitokai Tokito clinic /ID# 262661

Saitama-shi, Saitama, Japan

Tokorozawa Proctogic Hospital /ID# 268870

Tokorozawa, Saitama, Japan

Kato Clinic /ID# 262650

Hamamatsu, Shizuoka, Japan

Shizuoka Aoi Clinic /ID# 267376

Shizuoka, Shizuoka, Japan

Saigusa Clinic Of Coloproctolo /ID# 275627

Sizuoka-shi, Shizuoka, Japan

NHO Shizuoka Medical Center /ID# 275551

Sunto-gun, Shizuoka, Japan

Dokkyo Medical University Hospital /ID# 266710

Mibu, Tochigi, Japan

Saiseikai Utsunomiya Hospital /ID# 261878

Utsunomiya, Tochigi, Japan

Juntendo University Hospital /ID# 265452

Bunkyo-ku, Tokyo, Japan

Ginza Central Clinic /ID# 261881

Chuo-ku, Tokyo, Japan

Koganei Tsurukame Clinic /ID# 271660

Koganei-shi, Tokyo, Japan

Kitasato University Kitasato Institute Hospital /ID# 268345

Minato-ku, Tokyo, Japan

Ohori IBD Clinic /ID# 261882

Setagaya-ku, Tokyo, Japan

Shinjuku Tsurukame Clinic /ID# 276485

Shibuya-ku, Tokyo, Japan

Tokyo Medical University Hospital /ID# 262683

Shinjuku-ku, Tokyo, Japan

Tokyo Women's Medical University Hospital /ID# 274527

Shinjuku-ku, Tokyo, Japan

Fraternity Memorial Hospital /ID# 274976

Sumida-ku, Tokyo, Japan

Yokota Memorial Hospital /ID# 266714

Toyama, Toyama, Japan

Japanese Red Cross Wakayama Medical Center /ID# 268822

Wakayama, Wakayama, Japan

Wakayama Medical University Hospital /ID# 262685

Wakayama, Wakayama, Japan

Sentohill Hospital /ID# 268869

Ube, Yamaguchi, Japan

Yamanashi Prefectural Central Hospital /ID# 274526

Kofu, Yamanashi, Japan

Fukuiken Saiseikai Hospital /ID# 274835

Fukui, Japan

Fukushima Red Cross Hospital /ID# 275322

Fukushima, Japan

Japanease Red Cross Society Himeji Hospital /ID# 275590

Himeji, Japan

Kuniyoshi Hospital /ID# 271878

Kochi, Japan

Saga-Ken Medical Centre Koseikan /ID# 274957

Saga, Japan

Saitama City Hospital /ID# 266716

Saitama, Japan

Sapporo Kosei General Hospital /ID# 267374

Sapporo, Japan

Tokyo Yamate Medical Center /ID# 275591

Tokyo, Japan

Teikyo University Hospital /ID# 274525

Tokyo, Japan

Teikyo University Hospital /ID# 274977

Tokyo, Japan

Municipal Toyonaka Hospital /ID# 266712

Toyonaka, Japan

Yamagata Prefectural Central Hospital - Yamagata /ID# 268819

Yamagata, Japan

Yamaguchi Red Cross Hospital /ID# 267381

Yamaguchi, Japan

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NCT06023030

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