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
- Conditions
- Crohn's Disease
- Registration Number
- NCT06023030
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 240
- 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.
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Drug Related Serious Infections Up to 64 Weeks Pecentage of participants with serious infections.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (101)
Itami City Hospital /ID# 276258
🇯🇵Itami, Hyogo, Japan
Aoyama Clinic /ID# 262658
🇯🇵Kobe-shi, Hyogo, Japan
Japanease Red Cross Society Himeji Hospital /ID# 275590
🇯🇵Himeji, Japan
Kagoshima IBD Gastroenterology Clinic /ID# 265505
🇯🇵Kagoshima, 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
Kitasato University Kitasato Institute Hospital /ID# 268345
🇯🇵Tokyo, 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
Handa City Hospital /ID# 270446
🇯🇵Handa, Aichi, Japan
Anjou Kousei Hospital /ID# 261872
🇯🇵Anjo-shi, Aichi, Japan
Aichi Medical University Hospital /ID# 261871
🇯🇵Nagakute, Aichi, Japan
Nagoya City University Hospital /ID# 275588
🇯🇵Nagoya, Aichi, Japan
Masuko Memorial Hospital /ID# 267420
🇯🇵Nagoya, Aichi, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219
🇯🇵Nagoya, Aichi, Japan
Toyohashi Municipal Hospital /ID# 274975
🇯🇵Toyohashi, Aichi, Japan
Ieda Hospital /ID# 259754
🇯🇵Toyota-shi, Aichi, 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-shi, Ehime, Japan
Uwajima City Hospital /ID# 273444
🇯🇵Uwajima, Ehime, Japan
Fukuoka University Chikushi Hospital /ID# 262686
🇯🇵Chikushino-shi, Fukuoka, Japan
Kitakyushu Municipal Medical Center /ID# 276257
🇯🇵Kitakyushu, Fukuoka, Japan
Tobata Kyoritsu Hospital /ID# 273558
🇯🇵Kitakyushu, Fukuoka, Japan
Steel Memorial Yahata Hospital /ID# 272713
🇯🇵Kitakyushu, Fukuoka, Japan
Hakuai Clinic /ID# 261876
🇯🇵Kurume-shi, Fukuoka, Japan
Hidaka Colon Proctology Clinic /ID# 268867
🇯🇵Kurume, Fukuoka, Japan
Ashiya Central Hospital /ID# 275324
🇯🇵Onga-gun, Fukuoka, Japan
Southern Tohoku General Hospital /ID# 270447
🇯🇵Koriyama, Fukushima, Japan
Sakura Clinic /ID# 268344
🇯🇵Kakamigahara-shi, Gifu, Japan
NHO Fukuyama Medical Center /ID# 261873
🇯🇵Fukuyama-shi, Hiroshima, Japan
JA Hiroshima General Hospital /ID# 264432
🇯🇵Hatsukaichi, Hiroshima, Japan
Kaisei Clinic /ID# 261883
🇯🇵Hiroshima-shi, Hiroshima, Japan
Ako-City Hospital /ID# 271276
🇯🇵Ako, Hyogo, Japan
Himeji Chuo Hospital /ID# 272714
🇯🇵Himeji, Hyogo, Japan
Kobe City Medical Center General Hospital /ID# 270950
🇯🇵Kobe-shi, Hyogo, Japan
Hyogo Medical University Hospital /ID# 267383
🇯🇵Nishinomiya, Hyogo, Japan
Kita-Harima Medical Center /ID# 276256
🇯🇵Ono, Hyogo, Japan
Maeda Hospital /ID# 275554
🇯🇵Takamatsu-shi, Kagawa, Japan
Takamatsu Red Cross Hospital /ID# 268823
🇯🇵Takamatsu, Kagawa, 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
Yokohama Municipal Citizen's Hospital /ID# 267375
🇯🇵Yokohama-shi, Kanagawa, Japan
Inoue Gastroenterology Clinic /ID# 275555
🇯🇵Yokohama, Kanagawa, Japan
Saiseikai Yokohama Tobu Hospital /ID# 264186
🇯🇵Yokohama, Kanagawa, Japan
Hyogo Prefectural Harima-Himeji General Medical Center /ID# 274528
🇯🇵姫路市, Hyogo, Japan
Tsukuba Endoscopy clinic /ID# 261880
🇯🇵Tsukuba-shi, Ibaraki, Japan
National Hospital Organization Kanazawa Medical Center /ID# 268820
🇯🇵Kanazawa, Ishikawa, Japan
Chikamori Hospital /ID# 267382
🇯🇵Kochi City, Kochi, Japan
Coloproctology Center Takano Hospital /ID# 268868
🇯🇵Kumamoto-shi, Kumamoto, Japan
Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660
🇯🇵Kyoto-shi, Kyoto, Japan
National Hospital Organization Kyoto Medical Center /ID# 265461
🇯🇵Kyoto-shi, Kyoto, Japan
Mie University Hospital /ID# 262656
🇯🇵Tsu-shi, Mie, Japan
Yokkaichi Hazu Medical Center /ID# 260140
🇯🇵Yokkaichi-shi, Mie, Japan
Nagano Municipal Hospital /ID# 262627
🇯🇵Nagano-shi, Nagano, Japan
Honda Internal Medicine and Endoscopy Clinic /ID# 275628
🇯🇵Nagasaki-shi, Nagasaki, Japan
Ishida Clinic of IBD and Gastroenterology /ID# 261884
🇯🇵Oita-shi, Oita, 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 City, Osaka, Japan
Kinshukai Infusion Clinic /ID# 261332
🇯🇵Osaka-shi, Osaka, Japan
National Hospital Organization Osaka National Hospital /ID# 264230
🇯🇵Osaka-shi, Osaka, Japan
Osaka Metropolitan University Hospital /ID# 273559
🇯🇵Osaka-shi, Osaka, Japan
Tane General Hospital /ID# 268871
🇯🇵Osaka-shi, Osaka, Japan
Osaka Rosai Hospital /ID# 267379
🇯🇵Sakai City, 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-shi, Shizuoka, Japan
Shizuoka Medical Center /ID# 275551
🇯🇵Shimizu, Shizuoka, Japan
Shizuoka Aoi Clinic /ID# 267376
🇯🇵Shizuoka-shi, Shizuoka, Japan
Saigusa Clinic Of Coloproctolo /ID# 275627
🇯🇵Sizuoka-shi, Shizuoka, Japan
Dokkyo Medical University Hospital /ID# 266710
🇯🇵Mibu, Tochigi, Japan
Saiseikai Utsunomiya Hospital /ID# 261878
🇯🇵Utsunomiya-shi, 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
Ohori IBD Clinic /ID# 261882
🇯🇵Setagaya-ku, Tokyo, Japan
Shinjuku Tsurukame Clinic /ID# 276485
🇯🇵Shibuya, Tokyo, Japan
Tokyo Medical University Hospital /ID# 262683
🇯🇵Shinjuku-ku, Tokyo, Japan
Tokyo Women'S Medical University Hospital /ID# 274527
🇯🇵Shinjuku-ku, Tokyo, Japan
The Fraternity Memorial Hospital /ID# 274976
🇯🇵Sumida-ku, Tokyo, Japan
Yokota Memorial Hospital /ID# 266714
🇯🇵Toyama-shi, Toyama, Japan
Wakayama Medical University Hospital /ID# 262685
🇯🇵Wakayama-shi, 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
Gifu University Hospital /ID# 266711
🇯🇵Gifu, Japan
Japanese Red Cross Society - Wakayama Medical Center /ID# 268822
🇯🇵Wakayama, Japan
Yamagata Prefectural Central Hospital - Yamagata /ID# 268819
🇯🇵Yamagata, Japan
Yamaguchi Red Cross Hospital /ID# 267381
🇯🇵Yamaguchi, Japan