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
Recruiting · NCT06023030 · Observational (researchers observe without assigning treatment) · Lead sponsor: AbbVie
View the official record on ClinicalTrials.gov →What this trial is about
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.
Who can take part
Age range
15 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
60 locations listed.
- 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
- 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
Showing 60 of 104 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →