Crohn'sRecruiting
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
Observational · No treatment assigned · 104 sites · AbbVie
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Crohn's Disease. This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 15 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 3 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 240 participants are expected to take part.
- Start date: 2023-07-28.
- Main results expected around 2026-11 (estimate from the record).
- 104 study sites listed (104 marked recruiting) in Japan.
Main thing being measured
- Percentage of Participants with Drug Related Serious Infections (Up to 64 Weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Crohn's Disease |
| Lead sponsor | AbbVie |
| Enrollment | 240 (estimated) |
| Start date | 2023-07-28 |
| Primary completion (est.) | 2026-11 |
| First posted | 2023-09-05 |
| Last updated | 2026-02-24 |
| Official title | A Post-marketing Non-interventional Study for Upadacitinib in Patients With Moderately to Severely Active Crohn's Disease (CD) in Japan |
| ClinicalTrials.gov ID | NCT06023030 |
Interventions
- None listed
Full eligibility criteria (from the record)
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.
Locations (104)
Show all 104 sites
| Site | City | Country | Site status |
|---|---|---|---|
| Fukuiken Saiseikai Hospital /ID# 274835 | Fukui | Japan | Recruiting |
| Fukushima Red Cross Hospital /ID# 275322 | Fukushima | Japan | Recruiting |
| Japanease Red Cross Society Himeji Hospital /ID# 275590 | Himeji | Japan | Recruiting |
| Kuniyoshi Hospital /ID# 271878 | Kochi | Japan | Recruiting |
| Saga-Ken Medical Centre Koseikan /ID# 274957 | Saga | Japan | Recruiting |
| Saitama City Hospital /ID# 266716 | Saitama | Japan | Recruiting |
| Sapporo Kosei General Hospital /ID# 267374 | Sapporo | Japan | Recruiting |
| Tokyo Yamate Medical Center /ID# 275591 | Tokyo | Japan | Recruiting |
| Teikyo University Hospital /ID# 274525 | Tokyo | Japan | Recruiting |
| Teikyo University Hospital /ID# 274977 | Tokyo | Japan | Recruiting |
| Municipal Toyonaka Hospital /ID# 266712 | Toyonaka | Japan | Recruiting |
| Yamagata Prefectural Central Hospital - Yamagata /ID# 268819 | Yamagata | Japan | Recruiting |
| Yamaguchi Red Cross Hospital /ID# 267381 | Yamaguchi | Japan | Recruiting |
| 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 |
| Japanese Red Cross Kyoto Daiichi Hosital /ID# 262660 | Kyoto, Kyoto | Japan | Recruiting |
| National Hospital Organization Kyoto Medical Center /ID# 265461 | Kyoto, Kyoto | Japan | Recruiting |
| Mie University Hospital /ID# 262656 | Tsu, Mie-ken | Japan | Recruiting |
| Yokkaichi Hazu Medical Center /ID# 260140 | Yokkaichi-shi, Mie-ken | Japan | Recruiting |
| Nagano Municipal Hospital /ID# 262627 | Nagano, Nagano | Japan | Recruiting |
| Honda Internal Medicine and Endoscopy Clinic /ID# 275628 | Nagasaki, Nagasaki | Japan | Recruiting |
| Ishida Clinic of IBD and Gastroenterology /ID# 261884 | Ōita, Oita Prefecture | Japan | Recruiting |
| University of the Ryukyus Hospital /ID# 264430 | Ginowan-shi, Okinawa | Japan | Recruiting |
| Naha City Hospital /ID# 261875 | Naha, Okinawa | Japan | Recruiting |
| Seshimo Gastroy & Procto Clinic /ID# 271658 | Ibaraki-shi, Osaka | Japan | Recruiting |
| Moriguchi Keijinkai Hospital /ID# 268821 | Moriguchi, Osaka | Japan | Recruiting |
| Kinshukai Infusion Clinic /ID# 261332 | Osaka, Osaka | Japan | Recruiting |
| National Hospital Organization Osaka National Hospital /ID# 264230 | Osaka, Osaka | Japan | Recruiting |
| Osaka Metropolitan University Hospital /ID# 273559 | Osaka, Osaka | Japan | Recruiting |
| Tane General Hospital /ID# 268871 | Osaka, Osaka | Japan | Recruiting |
| Osaka Rosai Hospital /ID# 267379 | Sakai, Osaka | Japan | Recruiting |
| Fujita Gastroenterology Hospital /ID# 275410 | Takatsuki, Osaka | Japan | Recruiting |
| Ohmori Toshihide Gastrointestinal Clinic /ID# 276192 | Ageo, Saitama | Japan | Recruiting |
| Saitama Medical Center /ID# 270948 | Kawagoe, Saitama | Japan | Recruiting |
| Tokitokai Tokito clinic /ID# 262661 | Saitama-shi, Saitama | Japan | Recruiting |
| Tokorozawa Proctogic Hospital /ID# 268870 | Tokorozawa, Saitama | Japan | Recruiting |
| Kato Clinic /ID# 262650 | Hamamatsu, Shizuoka | Japan | Recruiting |
| Shizuoka Aoi Clinic /ID# 267376 | Shizuoka, Shizuoka | Japan | Recruiting |
| Saigusa Clinic Of Coloproctolo /ID# 275627 | Sizuoka-shi, Shizuoka | Japan | Recruiting |
| NHO Shizuoka Medical Center /ID# 275551 | Sunto-gun, Shizuoka | Japan | Recruiting |
| Dokkyo Medical University Hospital /ID# 266710 | Mibu, Tochigi | Japan | Recruiting |
| Saiseikai Utsunomiya Hospital /ID# 261878 | Utsunomiya, Tochigi | Japan | Recruiting |
| Juntendo University Hospital /ID# 265452 | Bunkyo-ku, Tokyo | Japan | Recruiting |
| Ginza Central Clinic /ID# 261881 | Chuo-ku, Tokyo | Japan | Recruiting |
| Koganei Tsurukame Clinic /ID# 271660 | Koganei-shi, Tokyo | Japan | Recruiting |
| Kitasato University Kitasato Institute Hospital /ID# 268345 | Minato-ku, Tokyo | Japan | Recruiting |
| Ohori IBD Clinic /ID# 261882 | Setagaya-ku, Tokyo | Japan | Recruiting |
| Shinjuku Tsurukame Clinic /ID# 276485 | Shibuya-ku, Tokyo | Japan | Recruiting |
| Tokyo Medical University Hospital /ID# 262683 | Shinjuku-ku, Tokyo | Japan | Recruiting |
| Tokyo Women's Medical University Hospital /ID# 274527 | Shinjuku-ku, Tokyo | Japan | Recruiting |
| Fraternity Memorial Hospital /ID# 274976 | Sumida-ku, Tokyo | Japan | Recruiting |
| Yokota Memorial Hospital /ID# 266714 | Toyama, Toyama | Japan | Recruiting |
| Japanese Red Cross Wakayama Medical Center /ID# 268822 | Wakayama, Wakayama | Japan | Recruiting |
| Wakayama Medical University Hospital /ID# 262685 | Wakayama, Wakayama | Japan | Recruiting |
| Sentohill Hospital /ID# 268869 | Ube, Yamaguchi | Japan | Recruiting |
| Yamanashi Prefectural Central Hospital /ID# 274526 | Kofu, Yamanashi | Japan | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.