Crohn's Disease Clinical Trial
Official title:
A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan
| NCT number | NCT06023030 |
| Other study ID # | P24-080 |
| Secondary ID | |
| Status | Recruiting |
| Phase | |
| First received | |
| Last updated | |
| Start date | July 28, 2023 |
| Est. completion date | November 30, 2026 |
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.
| Status | Recruiting |
| Enrollment | 240 |
| Est. completion date | November 30, 2026 |
| Est. primary completion date | November 30, 2026 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 15 Years and older |
| Eligibility | 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. |
| Country | Name | City | State |
|---|---|---|---|
| Japan | Anjou Kousei Hospital /ID# 261872 | Anjo-shi | Aichi |
| Japan | Fukuoka University Chikushi Hospital /ID# 262686 | Chikushino-shi | Fukuoka |
| Japan | Ginza Central Clinic /ID# 261881 | Chuo-ku | Tokyo |
| Japan | NHO Fukuyama Medical Center /ID# 261873 | Fukuyama-shi | Hiroshima |
| Japan | Hachinohe City Hospital /ID# 264183 | Hachinohe | Aomori |
| Japan | Kato Clinic /ID# 262650 | Hamamatsu-shi | Shizuoka |
| Japan | JA Hiroshima General Hospital /ID# 264432 | Hatsukaichi | Hiroshima |
| Japan | Kaisei Clinic /ID# 261883 | Hiroshima-shi | Hiroshima |
| Japan | Kagoshima IBD Gastroenterology Clinic /ID# 265505 | Kagoshima | |
| Japan | Gokeikai Ofuna Chuo Hospital /ID# 262649 | Kamakura-shi | Kanagawa |
| Japan | Tsujinaka Hospital Kashiwanoha /ID# 262648 | Kashiwa-shi | Chiba |
| Japan | Aoyama Clinic /ID# 262658 | Kobe-shi | Hyogo |
| Japan | Hakuai Clinic /ID# 261876 | Kurume-shi | Fukuoka |
| Japan | National Hospital Organization Kyoto Medical Center /ID# 265461 | Kyoto | |
| Japan | Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660 | Kyoto-shi | Kyoto |
| Japan | Dokkyo Medical University Hospital /ID# 266710 | Mibu | Tochigi |
| Japan | Aichi Medical University Hospital /ID# 261871 | Nagakute-shi | Aichi |
| Japan | Nagano Municipal Hospital /ID# 262627 | Nagano-shi | Nagano |
| Japan | Naha City Hospital /ID# 261875 | Naha | Okinawa |
| Japan | University of the Ryukyus Hospital /ID# 264430 | Nishihara | Okinawa |
| Japan | Hyogo Medical University Hospital /ID# 267383 | Nishinomiya | |
| Japan | Ishida Clinic of IBD and Gastroenterology /ID# 261884 | Oita-shi | Oita |
| Japan | National Hospital Organization Osaka Medical Center /ID# 264230 | Osaka | |
| Japan | Kinshukai Infusion Clinic /ID# 261332 | Osaka-shi | Osaka |
| Japan | Tokitokai Tokito clinic /ID# 262661 | Saitama-shi | Saitama |
| Japan | Sapporo Kosei General Hospital /ID# 267374 | Sapporo | |
| Japan | Ohori IBD Clinic /ID# 261882 | Setagaya-ku | Tokyo |
| Japan | Tokyo Medical University Hospital /ID# 262683 | Shinjuku-ku | Tokyo |
| Japan | Juntendo University Hospital /ID# 265452 | Tokyo | |
| Japan | Ieda Hospital /ID# 259754 | Toyota-shi | Aichi |
| Japan | Mie University Hospital /ID# 262656 | Tsu-shi | Mie |
| Japan | Tsukuba Endoscopy clinic /ID# 261880 | Tsukuba-shi | Ibaraki |
| Japan | Saiseikai Utsunomiya Hospital /ID# 261878 | Utsunomiya-shi | Tochigi |
| Japan | Wakayama Medical University Hospital /ID# 262685 | Wakayama-shi | Wakayama |
| Japan | Yokkaichi Hazu Medical Center /ID# 260140 | Yokkaichi-shi | Mie |
| Japan | Saiseikai Yokohama Tobu Hospital /ID# 264186 | Yokohama | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| AbbVie |
Japan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants with Drug Related Serious Infections | Pecentage of participants with serious infections. | Up to 64 Weeks |
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