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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

Recruitingn/aAges 15 Years - anyAllAbbVie
NCT06023030 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Not listed
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Where

104 sites
Anjou Kousei Hospital /ID# 261872
Anjo-shi, Japan
Handa City Hospital /ID# 270446
Handa, Japan
Aichi Medical University Hospital /ID# 261871
Nagakute, Japan
Masuko Memorial Hospital /ID# 267420
Nagoya, Japan
Japanese Red Cross Aichi Medical Center Nagoya Daiichi Hospital /ID# 276219
Nagoya, Japan
Nagoya City University Hospital /ID# 275588
Nagoya, Japan
Toyohashi Municipal Hospital /ID# 274975
Toyohashi, Japan
Ieda Hospital /ID# 259754
Toyota-shi, Japan

…and 96 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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