Assessing the effectiveness of upadacitinib for treating Crohn's disease in Japan
A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan
This study is testing if upadacitinib can help teenagers and adults in Japan with moderate to severe Crohn's disease feel better and stay safe while using the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 15 Years and up |
| Sex | All |
| Sponsor | AbbVie Industry-sponsored |
| Drugs / interventions | upadacitinib |
| Locations | 104 sites (Anjo-shi, Aichi-ken and 103 other locations) |
| Trial ID | NCT06023030 on ClinicalTrials.gov |
What this trial studies
This observational study evaluates the safety and effectiveness of upadacitinib in treating adolescents and adults with moderate to severe active Crohn's disease in Japan. Participants will receive upadacitinib as prescribed by their healthcare providers, and their disease activity and any adverse events will be monitored over a period of up to 64 weeks. Approximately 240 participants will be enrolled, and the study aims to reflect real-world clinical practices without imposing additional burdens on participants.
Who should consider this trial
Good fit: Ideal candidates include adolescents and adults diagnosed with moderately to severely active Crohn's disease who have been prescribed upadacitinib.
Not a fit: Patients who are currently participating in another interventional clinical research or for whom upadacitinib is contraindicated may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the real-world effectiveness and safety of upadacitinib for patients with Crohn's disease.
How similar studies have performed: Other studies have shown positive outcomes with upadacitinib for Crohn's disease, indicating that this approach is supported by prior evidence.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Anjo-shi, Aichi-ken and 103 other locations
- Anjou Kousei Hospital /ID# 261872 — Anjo-shi, Aichi-ken, Japan (Recruiting)
- Handa City Hospital /ID# 270446 — Handa, Aichi-ken, Japan (Recruiting)
- Aichi Medical University Hospital /ID# 261871 — Nagakute, Aichi-ken, Japan (Recruiting)
- Masuko Memorial Hospital /ID# 267420 — Nagoya, Aichi-ken, Japan (Recruiting)
- Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219 — Nagoya, Aichi-ken, Japan (Recruiting)
- Nagoya City University Hospital /ID# 275588 — Nagoya, Aichi-ken, Japan (Recruiting)
- Toyohashi Municipal Hospital /ID# 274975 — Toyohashi, Aichi-ken, Japan (Recruiting)
- Ieda Hospital /ID# 259754 — Toyota-shi, Aichi-ken, Japan (Recruiting)
- Hachinohe City Hospital /ID# 264183 — Hachinohe, Aomori, Japan (Recruiting)
- Tsujinaka Hospital - Kashiwanoha /ID# 262648 — Kashiwa-shi, Chiba, Japan (Recruiting)
- Matsuyama Red Cross Hospital /ID# 266717 — Matsuyama, Ehime, Japan (Recruiting)
- Uwajima City Hospital /ID# 273444 — Uwajima, Ehime, Japan (Recruiting)
- Fukuoka University Chikushi Hospital /ID# 262686 — Chikushino-shi, Fukuoka, Japan (Recruiting)
- Sakemi clinic /ID# 275589 — Fukuoka, Fukuoka, Japan (Recruiting)
- Tobata Kyoritsu Hospital /ID# 273558 — Kitakyushu, Fukuoka, Japan (Recruiting)
- Steel Memorial Yahata Hospital /ID# 272713 — Kitakyushu, Fukuoka, Japan (Recruiting)
- Kitakyushu Municipal Medical Center /ID# 276257 — Kitakyushu-shi, Fukuoka, Japan (Recruiting)
- Hidaka Colon Proctology Clinic /ID# 268867 — Kurume, Fukuoka, Japan (Recruiting)
- Hakuai Clinic /ID# 261876 — Kurume-shi, Fukuoka, Japan (Recruiting)
- Ashiya Central Hospital /ID# 275324 — Onga-gun, Fukuoka, Japan (Recruiting)
- Southern Tohoku General Hospital /ID# 270447 — Kōriyama, Fukushima, Japan (Recruiting)
- Gifu University Hospital /ID# 266711 — Gifu, Gifu, Japan (Recruiting)
- Sakura Clinic /ID# 268344 — Kakamigahara-shi, Gifu, Japan (Recruiting)
- National Hospital Organization Fukuyama Medical Center /ID# 261873 — Fukuyama-shi, Hiroshima, Japan (Recruiting)
- JA Hiroshima General Hospital /ID# 264432 — Hatsukaichi, Hiroshima, Japan (Recruiting)
- Kaisei Clinic /ID# 261883 — Hiroshima, Hiroshima, Japan (Recruiting)
- Sapporo Ibd Clinic /ID# 281896 — Sapporo, Hokkaido, Japan (Recruiting)
- Ako-City Hospital /ID# 271276 — Ako, Hyōgo, Japan (Recruiting)
- Himeji Chuo Hospital /ID# 272714 — Himeji, Hyōgo, Japan (Recruiting)
- Hyogo Prefectural Harima-Himeji General Medical Center /ID# 274528 — Himeji-shi, Hyōgo, Japan (Recruiting)
- Itami City Hospital /ID# 276258 — Itami, Hyōgo, Japan (Recruiting)
- Aoyama Clinic /ID# 262658 — Kobe, Hyōgo, Japan (Recruiting)
- Kobe City Medical Center General Hospital /ID# 270950 — Kobe, Hyōgo, Japan (Recruiting)
- Hyogo Medical University Hospital /ID# 267383 — Nishinomiya-shi, Hyōgo, Japan (Recruiting)
- Kita-Harima Medical Center /ID# 276256 — Ono, Hyōgo, Japan (Recruiting)
- Tsukuba Endoscopy clinic /ID# 261880 — Tsukuba, Ibaraki, Japan (Recruiting)
- National Hospital Organization Kanazawa Medical Center /ID# 268820 — Kanazawa, Ishikawa-ken, Japan (Recruiting)
- Takamatsu Red Cross Hospital /ID# 268823 — Takamatsu, Kagawa-ken, Japan (Recruiting)
- Maeda Hospital /ID# 275554 — Takamatsu, Kagawa-ken, Japan (Recruiting)
- Kagoshima IBD Gastroenterology Clinic /ID# 265505 — Kagoshima, Kagoshima-ken, Japan (Recruiting)
- Tokai University Hospital /ID# 270949 — Isehara, Kanagawa, Japan (Recruiting)
- Gokeikai Ofuna Chuo Hospital /ID# 262649 — Kamakura-shi, Kanagawa, Japan (Recruiting)
- Shimizuogimachi Clinic /ID# 276278 — Odawara-shi, Kanagawa, Japan (Recruiting)
- Kitasato University Hospital /ID# 276524 — Sagamihara-shi, Kanagawa, Japan (Recruiting)
- Matsushima Hospital /ID# 276486 — Yokohama, Kanagawa, Japan (Recruiting)
- Yokohama Municipal Citizen's Hospital /ID# 267375 — Yokohama, Kanagawa, Japan (Recruiting)
- Inoue Gastroenterology Clinic /ID# 275555 — Yokohama, Kanagawa, Japan (Recruiting)
- Saiseikai Yokohama Tobu Hospital /ID# 264186 — Yokohama, Kanagawa, Japan (Recruiting)
- Chikamori Hospital /ID# 267382 — Kochi, Kochi, Japan (Recruiting)
- Coloproctology Center Takano Hospital /ID# 268868 — Kumamoto, Kumamoto, Japan (Recruiting)
+54 more sites — see ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: AbbVie GK Clinical Trial Registration Desk
- Email: abbvie_jpn_info_clingov@abbvie.com
- Phone: +81-3-4577-1111
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.