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Clinical Trials in Japan / NCT06023030
Recruiting Observational

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

NCT06023030 · tracked via the Priya Life Science Japan tracker
Sponsor
AbbVie
Phase
Observational
Started
2023-07-28
Last updated
2026-02-24

Condition(s) studied

Crohn's Disease

Study 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.

Eligibility

Sex
ALL
Min age
15 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Percentage of Participants with Drug Related Serious Infections — Up to 64 Weeks
    Pecentage of participants with serious infections.

Trial sites (104)

FacilityCityRegionStatus
Anjou Kousei Hospital /ID# 261872 Anjo-shi Aichi-ken Recruiting
Handa City Hospital /ID# 270446 Handa Aichi-ken Recruiting
Aichi Medical University Hospital /ID# 261871 Nagakute Aichi-ken Recruiting
Masuko Memorial Hospital /ID# 267420 Nagoya Aichi-ken Recruiting
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219 Nagoya Aichi-ken Recruiting
Nagoya City University Hospital /ID# 275588 Nagoya Aichi-ken Recruiting
Toyohashi Municipal Hospital /ID# 274975 Toyohashi Aichi-ken Recruiting
Ieda Hospital /ID# 259754 Toyota-shi Aichi-ken Recruiting
Hachinohe City Hospital /ID# 264183 Hachinohe Aomori Recruiting
Tsujinaka Hospital - Kashiwanoha /ID# 262648 Kashiwa-shi Chiba Recruiting
Matsuyama Red Cross Hospital /ID# 266717 Matsuyama Ehime Recruiting
Uwajima City Hospital /ID# 273444 Uwajima Ehime Recruiting
Fukuoka University Chikushi Hospital /ID# 262686 Chikushino-shi Fukuoka Recruiting
Sakemi clinic /ID# 275589 Fukuoka Fukuoka Recruiting
Tobata Kyoritsu Hospital /ID# 273558 Kitakyushu Fukuoka Recruiting
Steel Memorial Yahata Hospital /ID# 272713 Kitakyushu Fukuoka Recruiting
Kitakyushu Municipal Medical Center /ID# 276257 Kitakyushu-shi Fukuoka Recruiting
Hidaka Colon Proctology Clinic /ID# 268867 Kurume Fukuoka Recruiting
Hakuai Clinic /ID# 261876 Kurume-shi Fukuoka Recruiting
Ashiya Central Hospital /ID# 275324 Onga-gun Fukuoka Recruiting
Southern Tohoku General Hospital /ID# 270447 Kōriyama Fukushima Recruiting
Gifu University Hospital /ID# 266711 Gifu Gifu Recruiting
Sakura Clinic /ID# 268344 Kakamigahara-shi Gifu Recruiting
National Hospital Organization Fukuyama Medical Center /ID# 261873 Fukuyama-shi Hiroshima Recruiting
JA Hiroshima General Hospital /ID# 264432 Hatsukaichi Hiroshima Recruiting
Kaisei Clinic /ID# 261883 Hiroshima Hiroshima Recruiting
Sapporo Ibd Clinic /ID# 281896 Sapporo Hokkaido Recruiting
Ako-City Hospital /ID# 271276 Ako Hyōgo Recruiting
Himeji Chuo Hospital /ID# 272714 Himeji Hyōgo Recruiting
Hyogo Prefectural Harima-Himeji General Medical Center /ID# 274528 Himeji-shi Hyōgo Recruiting
Itami City Hospital /ID# 276258 Itami Hyōgo Recruiting
Aoyama Clinic /ID# 262658 Kobe Hyōgo Recruiting
Kobe City Medical Center General Hospital /ID# 270950 Kobe Hyōgo Recruiting
Hyogo Medical University Hospital /ID# 267383 Nishinomiya-shi Hyōgo Recruiting
Kita-Harima Medical Center /ID# 276256 Ono Hyōgo Recruiting
Tsukuba Endoscopy clinic /ID# 261880 Tsukuba Ibaraki Recruiting
National Hospital Organization Kanazawa Medical Center /ID# 268820 Kanazawa Ishikawa-ken Recruiting
Takamatsu Red Cross Hospital /ID# 268823 Takamatsu Kagawa-ken Recruiting
Maeda Hospital /ID# 275554 Takamatsu Kagawa-ken Recruiting
Kagoshima IBD Gastroenterology Clinic /ID# 265505 Kagoshima Kagoshima-ken Recruiting

+ 64 more sites — see the full list on the official registry below.

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Other trials for the same condition

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease Recruiting
A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD) Recruiting
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease Recruiting
An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD) Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06023030 on ClinicalTrials.gov ↗ ← All trials in Japan